Medication Maintenance Tips for Caregivers

Managing medications can be difficult to do, especially if you’re a senior caregiver. Helping someone else remember to take medications on time and work to find the right balance for them can seem like a daunting task. Thankfully, we’ve got a list of tips and tricks to help make things flow more smoothly.

Make Sure Providers Are Aware Of Vitamins And Supplements

Medical providers should be aware of any vitamins and supplements a person is taking. Regardless of how natural they are, they can interfere with medications and other treatments. For example, someone on blood thinners should not be taking a supplement with vitamin K. Most blood thinners work by inhibiting the production of this vitamin in the body. Taking a vitamin K supplement can negate the work of blood thinners.

Instructions

Make sure to go over medication instructions with the senior you’re caring for. If they are able to, they should know the names of each medication along with dosages and what times to take them. It doesn’t hurt to type up instructions about medications so that all information is in one place and easy to access. Consider adding in what side effects they should seek help for. That can serve as a list for caregivers and seniors to check on in case of adverse events.

Alarms

Set alarms to remind seniors to take their medications. There are many options to choose from. Smartphones allow you to set up reminders with different sounds each time which can help people differentiate between medication doses and other alerts. Electronic personal assistants like Alexa or Google Home can easily be used for reminders as well. If the senior you’re caring for struggles with newer technology, consider a few alarm clocks around the home.

Keep A List

Keeping a list of medications can help seniors and caregivers alike remember what medications are due at what time. Lists that have both a visual of what the medications look like and allow people to check off a medication dose can be useful tools. If you’re going with this kind of list, make sure that you have multiple copies. Placing one next to a pill organizer and another on the fridge can help remind people to take medication before they’ve even missed a dose.

Smartphone apps can also be helpful in tracking this information.

Follow Up

It’s important not to just set alarms or reminders, but check in to ensure that someone has taken their medication. It can be easy to turn off an alarm and still forget to take medication as scheduled. Following up with the senior in your life can remind them that they didn’t take their most recent dose.

Store Medications Properly

Most medications do best when stored between 68 and 77 degrees Fahrenheit. Additionally, many of them need to avoid humidity, direct sunlight and more. Medications should not be stored in vehicles, on windowsills or other sunny and warm spots or even in the bathroom. Consider storing them in a cool, dry space in the kitchen or living space.

When medications aren’t stored properly, it can affect their potency and make them potentially dangerous. If you’re concerned that your senior’s medications have been affected, here’s what you need to watch out for:

  • Odd smells
  • Discolored pills, tablets and injections
  • Cracked or crumbled pills
  • Pills and tablets that are stuck together
  • Creams and ointments that show separation
  • Cloudy injections

If you see these signs, contact your senior’s pharmacist as soon as possible.

Sort Medications Into Pill Organizers

Set aside time each week to go through the medication your senior takes and place them into pill organizers. These can make it easier to remember to take medications as prescribed or even transport them while traveling. Some organizers can remind people to take their medications and even alert others that a dose has been missed.

Make Sure All Caregivers Know About Medications

A sure way to have seniors miss their medication doses is to have senior caregivers who aren’t on the same page. Without everyone being in the know, it becomes increasingly difficult to set reminders and follow up with seniors about medication doses.

Plan Ahead For Refill Needs

Refills may come up on days where a senior is alone. When that’s the case, they may forget or be unable to pick up their refilled medications. Refills may even be due when someone is planning to be out of town. Make sure to plan ahead adequately for refills and work with a person’s pharmacist.

Consider Compounding Medications If Needed

Compounding is a process where medication is tailored to a person’s specific needs. This can help remove any dyes a patient is allergic to or turn a pill into liquid for those who struggle with swallowing pills.

Get Tips from A Medical Provider

When methods to help your senior aren’t working as well as you had hoped, take some time to check in with their medical providers. Nurses have amassed a wealth of information on improving their patients’ quality of life. They are likely to have some ideas on how to make managing medications more effective.

Always Communicate With Family Members

Whatever steps you take to maintain a senior’s medication schedule, make sure that you’re communicating any difficulties with the senior’s loved ones. Family should also always be aware of any medication changes. When so many seniors rely on a variety of paid and family caregivers, it’s incredibly important for everyone to be in the loop on the storage, administration and organization of all medications, vitamins and supplements.

Reinventing the Clinical Trial: Start at Ground Level

If each of us humans is a snowflake, unique in our genomic makeup, where’s my snowflake medicine? I asked that question from the platform at the ePharma Summit in New York in 2013, and have yet to get an answer. The challenge for the bioscience industry is, I believe, the classic randomized clinical trial. That design goes through four phases:

  • Phase 1: a small group of people are given the drug under study evaluate its safety, determine a safe dosage range, and identify side effects
  • Phase 2: a larger group is given the drug to evaluate its efficacy and safety in a larger population
  • Phase 3: large groups – plural – of people are given the drug to confirm its effectiveness, monitor side effects, compare it to other commonly-used treatments, and collect information that will allow the drug /treatment to be used safely
  • Phase 4: the drug is marketed while study continues to assess long-term effects and efficacy

Of course, before they even get to Phase 1, there have to be both the idea for the new treatment, and animal studies to determine what the substance or compound under study might do to a mouse or a monkey.

Science isn’t easy. The phrase “trial and error” came out of science labs, with many trials running up against the error wall by Phase 2. Since bioscience companies can sink about $1 billion-with-a-B into getting just one drug to market, it seems that the traditional clinical trial has turned into a pathway to NOT making scientific discoveries that can benefit humankind.

Then there’s the whole “who’s in charge here?” question. Clinical trials are now a global effort, with US and European pharma companies testing new treatments in Latin America, Russia, and China to gain traction in those emerging markets while simultaneously developing me-too drugs for their domestic markets. So, who’s in charge, the US Food and Drug Administration (FDA)? The European Medicines Agency (EMEA)? A player to be named later? The answer to the question seems to be “all of the above,” which adds to the complexity of the clinical trial process.

As digital technology has made data easier to collect and share, it would seem that clinical trials would be a great place to start intersecting with the quantified-self movement. The shift to electronic health records, the widening adoption of all sorts of health tracking devices, and the rise of (relatively) cheap genomic sequencing should signal an ability to identify conditions, and populations, eager to participate in clinical investigations. But so far, it hasn’t.

What might challenge that stasis? In November 2013, three major pharma companies – Novartis, Pfizer, and Eli Lilly – announced via the White House’s website that they had joined together in a clinical open innovation effort. That page on the White House’s site is gone now – changes in Presidential administrations will do that – but here’s a direct quote from that announcement:

“In order to connect patients and researchers, Novartis, Pfizer and Eli Lilly and Company, are partnering in the U.S. to provide a new platform to improve access to information about clinical trials. The platform will enhance clinicaltrials.gov and will provide more detailed and patient-friendly information about the trials, including a machine readable ‘target health profile’ to improve the ability of healthcare software to match individual health profiles to applicable clinical trials. As part of the project, patients can search for trials using their own Blue Button data.”

Five years later, and we’re still stuck on the slow train when it comes to really reinventing the clinical trial.

I’m one of a growing group of people who think that the entire life-sciences process chain needs to be re-tooled for the 21st century. In my view, the best place to start that re-tool is at ground level, with the patients and clinicians who deal with challenging medical conditions daily. If a doctor has a number of patients who might benefit from some clinical study, why isn’t there an easy way to find a researcher looking into that condition? If a patient has an idea for a clinical investigation into his or her illness or condition, why can’t they find a researcher who’s interested in the same condition to team up and start a science project?

I can only hope that the regulatory agencies involved in life science oversight (hello, FDA!) can move beyond the aftermath of Thalidomide – for which epic disaster we’re still paying a price when it comes to the timeline for drug approval in the US – and toward a process of “all deliberate speed” that doesn’t forsake speed for deliberation. Both are necessary, neither should be more heavily weighted than the other.

We all can, and should, take part in scientific exploration into human life, and human health. Got an idea for a clinical trial? Share that idea in the patient communities you hang out in, and ask your tribe to help you bring that trial to life. To quote Arthur Ashe, “Start where you are. Use what you have. Do what you can.”

We’ve got to start somewhere, right?

Talking To Your Family About Clinical Trial Decisions

Hearing your name and the word “cancer” in the same sentence is a world-shaking moment. After getting a cancer diagnosis, telling your family about it is another big step, one that can be fraught with as much emotion as hearing that diagnosis yourself.

Once the emotional dust has settled, talking with your family about treatment options, including clinical trials, can raise the emotional temperature again. If your family is like mine, everyone has an opinion, and is more than ready to share it. Even in families where everyone is calm about big issues like this – I question that those families exist, but I’ve heard they might – talking about clinical trials as a treatment option means being ready to field questions, and guide the conversation.

The American Cancer Society has a great set of resources for people who are assessing whether clinical trials are a good option for their treatment. I’ll use some of those as a framework for a discussion guide you can use to walk your family through your decision to explore clinical trials for your cancer:

  • Why do I want to participate in a clinical trial?
    • Your reasons can be anything from “I want to try cutting edge treatments” to “my cancer is advanced stage, and I want to throw everything but the kitchen sink at it.” The key here is to have an answer ready to this question when you discuss treatment options with your family.What are the risks?
  • What are the risks?
    • Here’s another question you’ll want to gather answers for, for yourself, before opening a conversation with your family about enrolling in a trial. Your oncology team can help you put together a risk profile for trials, and further help you target the right trials via molecular profiling of your cancer.
  • Will my insurance cover the trial?
    • Federal law requires that most insurers cover routine costs of cancer trials. However, like so much about US health insurance, the answer can still be “it depends.” There’s a great tip-sheet on the National Cancer Institute’s site that addresses this topic. You, and your family, and your oncology team, will be working together to make sure your costs are covered, either by your insurer or the trial sponsor.
  • What happens if I’m harmed by the trial – what treatment will I be entitled to?
    • Here’s another “it depends” situation. Addressing harm to trial participants is an ongoing ethics issue in the US. The key here is to review all trial enrollment documentation fully – with help from a medical ethicist or legal eagle who’s not involved with the trial, or your oncology team – and have any potential harm scenario fully spelled out, including who will address the remedy for harm, and how that remedy will be delivered.

Having solid family support is a key factor in managing cancer treatment, and in thriving as a cancer survivor. Getting your family involved in your care by talking through your options and decisions with them will give them a sense of involvement in your care, and its outcome. They can help you through the down days when side effects have you feeling punky, and celebrate the bright days with you when scans show progress against your cancer.

Curing cancer is a team sport. You, your family, and your oncologists are all on that team. Work together toward a win, which often includes unlocking the power of precision medicine via clinical trials – which can become a win for other cancer patients, too.

Talking to Your Oncologist About Clinical Trials

You’ve gotten a cancer diagnosis. You’ve selected an oncologist as your partner, working toward “No Evidence of Disease,” or NED (NED is every cancer patient’s very best friend). Your and your oncologist are working up a treatment plan, and you want to talk about clinical trials as part of that plan. Should you kick off that discussion, or wait until your onc brings it up?

YES, definitely bring up clinical trials yourself, if your oncologist hasn’t started that conversation. If you’re not sure how to kick off that discussion, here are some tips.

  • “Just do it.” Lace up your mental Nikes, and just ask the question. Have some resource links handy at your next oncology team visit, or start the conversation before the visit via your onc’s patient portal. Start with the information on the Patient Empowerment Network’s Health Centers and Programs hub, take a dive into gov, or check out the American Society of Clinical Oncology’s Cancer.Net trials site.
  • There’s an article in the Journal of Oncology Practice, “Identifying and Selecting a Clinical Trial for Your Practice,” that talks clinicians through the process of selecting clinical trials for their oncology practice. Reading through that can help you craft some great questions, and open a productive conversation with your treatment team about clinical trials for your cancer.
  • The National Institutes of Health has a great tip-sheet for oncologists on how to talk to their patients about clinical trials. You can use that to frame the conversation you’d like to have with your own oncologist about your clinical trial options. I’ve often found that reading articles and tip-sheets aimed at the clinical side of the equation have helped me accelerate discussions with my own clinical teams about treatment options, for cancer and for other medical conditions.

When you’re dealing with a cancer diagnosis, you want to have all your options on the table, and make the most informed decisions possible. Opening up a dialogue with your oncology team about clinical trials early in the treatment process will give you the information you need for those “most informed decisions.”

Another reason to open those discussions early is to gauge your oncologist’s response to shared decision making, and participatory medicine. If your oncologist doesn’t welcome self-advocacy on your part, it’s better to know early in the treatment process so you can shift to another, more participatory practice.

You are the focus of your cancer treatment team’s work. Lead the discussions, share your perspective, and participate fully in your treatment planning. Opening the discussing of clinical trials is a great way to get your team on your page about treatment and outcome preferences, and to unlock the power of precision medicine.

A How-To On Reading Scientific Papers

“Be skeptical. But when you get proof, accept proof.” – Michael Specter

That quote is from Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet, and Threatens Our Lives, where New Yorker staff writer Michael Specter examined the distrust of science that’s turned discussion of scientific topics into a potential minefield. Some good examples of that minefield are climate change, and childhood vaccinations.

Anyone interested in scientific progress – full disclosure, I’m in that group – needs to understand the ideas being explored in scientific papers, the dispatches from the front lines of scientific thinking and discovery. To arrive at that understanding, you have to be able to understand what you’re reading, and I’ll be the first to admit that isn’t easy.

Scientific papers are written by scientists, for scientists, and follow a set of rules and formal structures that can feel like they’re designed to prevent any understanding by the average Joe/Jane “just plain human.” In this post, my goal is to help anyone interested in, but not formally trained in, science tackle reading – and understanding! – an article in any scientific journal.

10 steps to scientific (article) understanding

  1. Check the source

    • What journal is publishing the article? Check Beall’s List, and if the journal appears there, you can stop reading – it’s a fake journal.
    • Who is the lead author, and what organization or institution is s/he affiliated with? If it’s an established university or research institute (University of Chicago or Scripps Institute, for example), keep reading.
  2. Read the introduction first, not the abstract

    • The introduction will reveal the Big Question, the one that the research project worked to reveal the answer to. For instance, an article in the Christmas 2017 issue of The BMJ reports on research into the effects of pet ownership on human biomarkers of ageing; the introduction clearly lays out the Big Question as “ we examined the prospective link between pet ownership and a selected range of objective biomarkers of ageing proposed for use in large scale population based studies of older people.”
  3. Write out your own summary of what the research was examining

    • This will give you a grasp of why the researchers wanted to ask the Big Question, and a framework for assessing what their answers to that question are.
  4. Identify the null hypothesis

    • The null hypothesis could really be better termed the “nullifiable” hypothesis, since the purpose of the research project is to nullify the hypothesis that there are no differences in possible answers to the Big Question.
    • An example of a null hypothesis is “the world is flat,” which is what Copernicus worked to scientifically disprove a while back. He was successful, but there are some people who still reject his conclusions. (Warning: opening that link might be hazardous to your sanity.)
  5. Look at the approach, and the methods, used in the research study or experiment(s)

    • What did the researchers do to answer the Big Question? What specific experiments did they run?
    • Sketch out diagrams of each experiment or data crunch.
  6. Read the results section of the article

    • Look at the written results, as well as all charts and figures related to those results.
    • What are the sample sizes? Really small sample sizes are a red flag.
    • What results are listed as “significant,” and what as “non-significant”? If you want to totally geek out on this topic, this post will make your geeky day.
  7. Do the results actually answer the Big Question?

    • Using your own judgment, do you think the study authors have answered the question asked in the introduction?
    • Do this before you read the paper’s conclusion.
  8. Does the conclusion make sense, in light of everything you’ve read and evaluated while going through the paper?

    • Do you agree with the conclusion?
    • Can you identify an alternative explanation for the results in the article?
    • What are the next steps the authors see emerging from their research?
  9. Read the abstract at the beginning of the paper

    • In light of the work you did in Steps 1 through 8, does the abstract line up with what the authors said their research purpose was?
    • Does it fit with your own interpretation of the paper?
  10. What are other scientists saying about the paper?

    • Have other scientists written about this paper?
    • What other research is referenced in the paper?
    • Have the authors of that research weighed in on the paper you’re evaluating?

Reading, and understanding, scientific papers takes practice. It’s also fun, if you’re a science nerd, or just interested in new scientific discoveries. And it’s work worth doing, because the more you know, the more likely it is that you yourself might make a discovery that makes a difference.

Paying It Forward: Volunteering for Clinical Trials

Editor’s Note: This blog and video is from the Alliance for Aging Research. The Alliance for Aging Research is dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health.

Getting medical discoveries from the research lab to patients depends on clinical trials and the people who volunteer to participate in them.   Volunteering in a trial may help society at large by bringing new treatments one step closer to patients, and could help a loved one if you have a genetic disease or condition.  Volunteering may also give you access to a cutting-edge treatment and medical team that carefully monitors your health.  But clinical trials can’t happen without volunteers, and 37% of trials don’t enroll enough patients to move forward.  Clinical trials need volunteers like you so watch this short film to find out more about why they are important, how to get involved, and what it means to participate.

How to Read and Understand a Scientific Paper

In a previous article, How to Read Beyond the Headline: 9 Essential Questions to Evaluate Medical News, I recommended you should always try to read an original study (if cited) to evaluate the information presented. In this follow-on article, you will learn how to read a scientific research paper so that you can come to an informed opinion on the latest research in your field of interest.  Understanding research literature is an important skill for patient advocates, and as with any skill, it can be learned with practice and time.

Let’s start by looking at what exactly we mean by the term “scientific paper”. Scientific papers are written reports describing original research findings. They are published in peer reviewed journals, which means they have been refereed by at least two other experts (unpaid and anonymized) in the field of study in order to determine the article’s scientific validity.

You may also come across the following types of scientific papers in the course of your research.

•       Scientific review papers are also published in peer reviewed journals, but seek to synthesize and summarize the work of a particular sub-field, rather than report on new results.

•       Conference proceedings, which may be published in a journal, are referred to as the “Proceedings of Conference X”. They will sometimes go through peer review, but not always.

•       Editorials, commentaries and letters to the editor offer a review or critique of original articles. They are not peer-reviewed.

Most scientific journals follow the IMRD format, meaning its publications will usually consist of an Abstract followed by:

•       Introduction

•       Methods

•       Results

•       Discussion

 

Let’s look at each of these sections in turn.

(a) Introduction  

The Introduction should provide you with enough information to understand the article. It should establish the scientific significance of the study and demonstrate a relevant context for the current study.  The scope and objectives of the study should be clearly stated.

When reading the Introduction, ask yourself the following questions:

·       What specific problem does this research address?

·       Why is this study important?

(b) Methods

The Methods section outlines how the work was done to answer the study’s hypothesis. It should explain new methodology in detail and types of data recorded.

As you read this section, look for answers to the following questions:

  • What procedures were followed?
  • Are the treatments clearly described?
  • How many people did the research study include? In general, the larger a study the more you can trust its results. Small studies may miss important differences because they lack statistical power. Case studies (i.e. those based on single patients or single observations) are no longer regarded as scientific rigorous.
  • Did the study include a control group? A control group allows researchers to compare outcomes in those who receive a treatment with those who don’t.

 (c) Results

The Results section presents the study’s findings.  It should follow a logical sequence to answer the study hypothesis.  Pay careful attention to any data sets shown in graphs, tables, and diagrams. Try to interpret the data first before reading the captions and details.  If you are unfamiliar with statistics, you will find a helpful glossary of terms hereClick here for an online guide to help you understand key concepts of statistics and how these concepts relate to the scientific method and research.

Consider the following questions:

  • Are the findings supported by persuasive evidence?
  • Is there an alternative way to interpret these findings?

(d) Discussion 

The Discussion places the study in the context of the broader field of research. It should explain how the research has moved the body of scientific knowledge forward and outline the next steps for further study.

Questions to ask:

•       Does the study have any limitations? Limitations are the conditions or influences that cannot be controlled by the researcher.  Any limitations that might influence the results should be mentioned in the study’s findings.

  • How are the findings new or supportive of other work in the field?
  • What are some of the specific applications of the study’s findings?

The IMRD format provides you with a useful framework to read a scientific paper. You will need to read a paper several times to understand its findings. Consider your first reading of the study as a “big picture” reading.  Scan the Abstract for a summary of the study’s principal objectives, the methods it used and the principal conclusions. A well-written abstract should allow you to identify the basic content of an article to determine its relevance to you.  In describing how she determines the relevance of a study, research RN, Katy Hanlon, focuses on “key words and phrases first. Those that relate to the author/s base proposal as well as my own interests”.  Medical writer, Nora Cutcliffe, also scans upfront “to gauge power and relevance of clinical trial data”. She looks for “study enrollment (n), country and year”. It’s important to note the publication date to determine if this article contains the latest findings or if there is more up-to-date research available. Cutcliffe also advises you should “note author affiliations and study sponsors”.  Here you are looking out for any potential bias or vested interest in a particular outcome.  Check the Acknowledgments section to see if the author(s) declare any financial interests in the research which might bias their findings. Finally, check if the article is published in a credible journal.  You will find reputable biomedical journals indexed by Pubmed and Web of Science.

Next, circle or take note of any scientific terms or keywords you don’t understand and look up their meaning before your second reading. Scan the References section – you may even want to read an article listed here first to help you better understand the current study.

With the second reading you are going to deepen your comprehension of the study. You’ll want to highlight key points, consult the references, and take notes as you read.  According to the scientific publisher, Elsevier, “reading a scientific paper should not be done in a linear way (from beginning to end); instead, it should be done strategically and with a critical mindset, questioning your understanding and the findings.”  Scientist, Dr Jennifer Raff, agrees. “When I’m choosing papers to read, I decide what’s relevant to my interests based on a combination of the title and abstract”, she writes in How to read and understand a scientific paper: a guide for non-scientists. “But when I’ve got a collection of papers assembled for deep reading, I always read the abstract last”. Raff explains she does this “because abstracts contain a succinct summary of the entire paper, and I’m concerned about inadvertently becoming biased by the authors’ interpretation of the results”.

When you have read the article through several times, try to distill it down to its scientific essence, using your own words. Write down the key points you have gleaned from your reading such as the purpose of the study, main findings and conclusions. You might find it helpful to develop a template for recording notes, or adapt the template below for use. You will then have a useful resource to find the correct reference and to cross reference when you want to consult an article in the future.

In the example below I have taken an article published in 2015, as an example. You can read the paper Twitter Social Media is an Effective Tool for Breast Cancer Patient Education and Support: Patient-Reported Outcomes by Survey on PubMed.

Template for Taking Notes on Research Articles

 

 

Further reading

Nothing About Us Without Us: Patient Involvement in Research

Until recently, patient participation in research was limited to their involvement as subjects enrolled in research studies, but there is a shift occurring as funding bodies increasingly look for evidence of patient and public involvement (PPI) in research proposals. The rationale for this is increasing evidence that PPI in the provision of healthcare leads to improved outcomes and better quality of care.

Assumptions are made every day about patients; assumptions which may lead to a failure to deliver optimum care. When these assumptions extend to research, quite often there is a mismatch between the questions that patients want answers to and the ones that researchers are investigating. As an example, the research priorities of patients with osteoarthritis of the knee, and the clinicians looking after them, were shown in a study to favor more rigorous evaluation of physiotherapy and surgery, and assessment of educational and coping strategies. Only 9% of patients wanted more research on drugs, yet over 80% of randomized controlled trials in patients with osteoarthritis of the knee were drug evaluations. PPI recognizes that patients bring a unique perspective and experience to the decision-making process in research. It is paternalistic and patronizing to rely on speculation about patient experience. By considering the actual experience of patients, researchers can make more informed research decisions. Involving patients is an important step in ensuring that the real life experiences of patients are considered when it comes to setting research priorities. This in turn will increase the relevance of research to patients and improve research quality and outcomes.

As an advocate you may be asked to become involved in a research project, so it is important to have a clear understanding of what PPI is – and what it isn’t. PPI is not about being recruited as a participant in a clinical trial or other research project, donating sample material for research, answering questionnaires or providing opinions. PPI describes a variety of ways that researchers engage with people for whom their research holds relevance. It spans a spectrum of involvement which may include any of the following:

  • Being involved in defining the research question
  • Being a co-applicant in a research proposal
  • Working with funders to review patient-focused section of applications
  • Being an active member of a steering group for a research study
  • Providing your input into a study’s conception and design
  • Contributing to/proofing of documentation
  • Assisting in the implementation and dissemination of research outcomes
  • Improving access to patients via peer networks and accessing difficult-to-reach patients and groups

Effective PPI transforms the traditional research hierarchy in which studies are done to, on, or for participants into a partnership model in which research is carried out with or by patients.  PPI should always involve meaningful patient participation and avoid tokenism. The Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) describes PPI as fostering a climate in which researchers, health care providers, decision-makers and policy-makers understand the value of patient involvement and patients see the value of these interactions. Underpinning this framework are the following guiding principles for integrating patient engagement into research:

  • Inclusiveness:Patient engagement in research integrates a diversity of patient perspectives and research is reflective of their contribution.
  • Support:Adequate support and flexibility are provided to patient participants to ensure that they can contribute fully to discussions and decisions. This implies creating safe environments that promote honest interactions, cultural competence, training, and education. Support also implies financial compensation for their involvement.
  • Mutual Respect:Researchers, practitioners and patients acknowledge and value each other’s expertise and experiential knowledge.
  • Co-Build:Patients, researchers and practitioners work together from the beginning to identify problems and gaps, set priorities for research and work together to produce and implement solutions.

Derek Stewart, a patient advocate and Associate Director for Patient and Public Involvement at NIHR Clinical Research Network, sees a growing momentum of actively involving patients and public in research gathering pace worldwide. “It is really pleasing to hear researchers saying how valuable it has been to involve patients and the public in their work”, he says. “It has equally improved the quality of the research and enriched their own thinking and understanding.”

Earlier this year, PCORnet, the National Patient-Centered Clinical Research Network, announced its first demonstration study which reflects PCORnet’s aims of patient engagement and open science. ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) will compare the effect of two different aspirin doses given to prevent heart attacks and strokes in high-risk patients with a history of heart disease. Seeking input at every critical step, from consent design and protocol development, through dissemination of final study results, the project represents a new research paradigm. Unprecedented in the design of clinical trials, the final consent form and protocol were shaped with input from patients, local institutional review boards, physicians, and study coordinators.

Another noteworthy example of PPI can be found in the Metastatic Breast Cancer Project a direct-to-patients initiative launched at the Broad Institute of MIT and Harvard last October. Corrie Painter, an angiosarcoma patient and Associate Director of Operations and Scientific Outreach at Broad Institute, explains that “the project seeks to greatly accelerate the pace of biomedical research by empowering patients to directly contribute to research and was built in lock step from design to consent language with dozens of patients.”

To what extent you may wish to be involved in PPI will depend on several factors. Do you have professional experience (e.g. project management, clinical experience, etc.) which would be useful? Are you happy to work as part of a team? Or would you prefer to work on your own? You should also take into consideration your other work or family commitments. For instance will you need to take time off work to attend meetings? Consider also at what point you are in your own health journey. Will participation in research place an added burden on your treatment or recovery? In making the decision to become involved in research, you should always balance your own health needs with the desire to be supportive of research and the research process.

 

Useful links

PCORI www.pcori.org

PCORnet www.pcornet.org

Metastatic Breast Cancer Project www.mbcproject.org

#WhyWeDoResearch www.whywedoresearch.weebly.com

How to Read Beyond the Headline: 9 Essential Questions to Evaluate Medical News

Ben Goldacre writing in Bad Science classified science reporting as falling into three categories – wacky stories, scare stories and breakthrough stories; the last of which he views as ”a more subtly destructive category of science story”. Whether you get your news through digital or traditional means, you can’t fail to notice the regularity with which journalists report on the latest medical breakthroughs. Some of these reports are sensationalist (“coffee causes cancer”) and fairly easy to dismiss; but do you know how to separate fact from fiction when it comes to less sensationalist headlines?

The foundation of empowered patient-hood is built on reliable health information. This means not only knowing where to find medical information, but being able to evaluate it and knowing how it can be applied to your own, or your loved-ones’ particular circumstances. Headlines often mislead people into thinking a certain substance or activity will prevent or cure chronic disease. As patient advocates we must learn to read beyond the headlines to filter out the good, the bad, and the questionable. The following questions are designed to help sort the signal from the noise next time you read the latest news story heralding a medical breakthrough.

1. Does the article support its claims with scientific research?

Your first concern should be the research behind the news article. If an article contains no link to scientific research to support its claims, then be very wary about treating those claims as scientifically credible.

2. What is the original source of the article?

If the article cites scientific research you should still treat the findings with caution. Always consider the source. Find out where the study was done. Who paid for and conducted the study? Is there a potential conflict of interest?

3. Does the article contain expert commentary to back up claims?

Look for expert independent commentary from doctors or other healthcare providers to explain the findings (there should be an independent expert source quoted – someone not directly connected with the research).

4. Is this a conference presentation?

Journalists frequently report on research presented at large scientific meetings. It’s important to realize that this research may only be at a preliminary stage and may not fulfill its early promise.

5. What kind of clinical trial is being reported on?

If the news relates to results from a clinical trial, it’s important you understand how, or even if, the results apply to you. Quite often, news publications report on trials which have not yet been conducted on humans. Many drugs that show promising results in animals don’t work in humans. Cancer.Net and American Cancer Society have useful guides to understanding the format of cancer research studies.

6. What stage is the trial at?

Research studies must go through several phases before a treatment can be considered safe and effective; but many times journalists report on early phase trials as if these hold all the answers. The testing process in humans is divided into several phases:

  •  Phase I trials: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II trials: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III trials: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Source: ClinicalTrials.gov

7. How many people did the research study include?

In general, the larger a study the more you can trust its results. Small studies may miss important differences because they lack statistical power.

8. Did the study include a control group?

A control group allows researchers to compare outcomes in those who receive a treatment with those who don’t. The gold standard is a “randomised controlled trial”, a study in which participants are randomly allocated to receive (or not receive) a particular intervention (e.g. a treatment or a placebo).

9. What are the study’s limitations?

Many news stories fail to point out the limitations of the evidence. The limitations of a study are the shortcomings, conditions or influences that cannot be controlled by the researcher. Any limitations that might influence the results should be mentioned in the study’s findings, so always read the original study where possible.

Useful Resources

  • Gary Schweitzer’s Health News Review website provides many useful resources to help you determine the trustworthiness of medical news. To date, it has reviewed more than 1,000 news stories concerning claims made for treatments, tests, products and procedures.
  • Sense about Science works with scientists and members of the public to equip people to make sense of science and evidence. It responds to hundreds of requests for independent advice and questions on scientific evidence each year.
  • Trust It or Trash is a tool to help you think critically about the quality of health information (including websites, handouts, booklets, etc.).
  • Understanding Health Research (UHR) is a free service created with the intention of helping people better understand health research in context. It gives clear and understandable explanations of important considerations like sampling, bias, uncertainty and replicability.

Heading Off Cancer Growth on the Cellular Level

Cancer cells are like all the cells in our body, in that they need certain basic building blocks – amino acids – in order to reproduce. There are 20 amino acids found in nature. The amino acid serine is often found in abundance in patients with certain types of breast cancer, lung cancer, and melanoma. The overproduction of this amino acid is often required for the rapid and unregulated growth characteristic of cancer.

Scientists at the Scripps Research Institute (TSRI) wondered if there was a way to take advantage of the relationship between cancer cell proliferation and serine. Amy GrayThey examined a large library of molecules -numbering 800,000 – to find an enzyme that inhibited serine production. After much research, the group found 408 contenders that could possibly work. This list was again narrowed down to a smaller set of seven, ending with one promising candidate. This molecule, 3-phosphoglycerate dehydrogenase (PHGDH), seemed to inhibit the first step in a cancer cell’s use of serine to reproduce itself.

Luke L. Lairson, assistant professor of chemistry at TSRI and principal investigator of cell biology at the California Institute for Biomedical Research remarked, “In addition to discovering an inhibitor that targets cancer metabolism, we also now have a tool to help answer interesting questions about serine metabolism.”

What does this mean for cancer patients in the future?

Discovering an enzyme that inhibits serine production means that a key process in cancer cell proliferation can be slowed down or even stopped.   Interfering with cancer cell metabolism could be a pathway to treatment. Potentially, adding the molecule PHGDH to cancer cells disturbs the basic need of cancer cells to divide and reproduce rapidly. Obviously this finding points to years of further research and drug development. But discovering this key relationship between serine over-production and a molecule that slows it down could be a model for new cancer treatments in the future.

 

References:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3989988/

http://medicalxpress.com/news/2016-03-team-approach-curbing-cancer-cell.html

Can Digital Wearables Help in Clinical Trials?

Today’s healthcare consumer can log and produce a range of data through wearable devices, smart fabrics, and intelligent sensors that are worn on the body or incorporated into garments and accessories, such as wristbands and watches. To date, wearables have been limited to tracking information related to health and fitness, but as the technology behind wearables for healthcare evolves, there is a growing interest in its potential in medical settings. New wearables show promise for addressing a range of medical conditions from diabetes to dementia. When applied to clinical trials, wearable technology is a potentially powerful research tool to gather clinical data in real-time and provide remote patient monitoring.

digital wearables

photo from http://www.alivecor.com/home

The clinical trials process could be optimized by leveraging existing smart technology, such as electrocardiogram (ECG) monitors like AliveCor, which enables anytime recording of ECGs; and smart pill technology (also known as “ingestibles”) which allows for both wireless patient monitoring and diagnostic imaging. Digital health company Proteus Digital has developed FDA approved wearable and ingestible sensors that work together to detect ingestions and physiologic data. The sensor is taken alongside medications, and is powered by the body’s biochemistry. The patch, body-worn and disposable, receives the data from the ingestible sensor, tracking medication-taking, steps, activity, rest, and heart rate and forwards that information to a Bluetooth enabled mobile device. If life science companies can get enough insight early in development, they can potentially create a more efficient drug development process and prioritize resources for the most promising therapies, with the goal of getting effective drugs to market faster.

Clinical use adoption will depend on ease of use, relevance and accuracy. Google’s life sciences division at Google X is in the process of developing a wearable health sensor specifically for use in clinical trials. The developers, who have already created a glucose-sensing contact lens, want to see how a continuous stream of medical-grade measurements of biological signals could be used to help earlier diagnosis or intervention in disease. The prototype wrist-worn sensor measures pulse, activity level, and skin temperature, alongside environmental information like light exposure and noise levels. Right now, it isn’t clear how Google’s prototype device will collect, analyse, and interpret data and incorporate information into a clinical trial data feed.  Issues of data standards and security will also need to be worked through. Google is in the early stages of the project, which will work with academic researchers and drug makers to test the wristband’s accuracy and seek regulatory clearance in the U.S. and Europe. The project will also draw on Google’s ongoing Baseline study, a medical and genomics project involving Stanford University and Duke University, which aims to map a healthy human body. Google Baseline will use a combination of genetic testing and digital health sensors to collect “baseline” data on healthy people. The project aims to establish genetic biomarkers relating to how we metabolize food, nutrients and drugs, how fast our hearts beat under stress, and how chemical reactions change the behavior of our genes.

Google’s wearable prototype, and other similar existing wearable devices, could give researchers insights that are currently only available intermittently (e.g. via a diagnostic test, or when a patient is being observed in a clinical setting).   Using sensors and wearables, drug efficacy and clinical trials outcomes might be better assessed through a variety of data points. It also allows for more objective measurement of data. For instance, obtaining objective metrics of hours of sleep in a clinical trial can be difficult to measure in a traditional trial setting when patients record this information at home. Being able to measure hours of sleep objectively through a wearable device could provide more complete data, although researchers still need to consider the context within which all data is captured. Having structured analysis of supplementary data may provide the additional evidence needed to show the benefits of a certain drug. However, more data does not necessarily translate into better data. The use of a wearable device alone does not add value to the clinical trial process. The real value lies in the ability to extract raw data and leverage real-time analytics to monitor trial progress in the moment, thereby facilitating early intervention which may reduce trial risks. In addition, continuous tracking of vital signs outside of a laboratory provides patients with better support through remote patient monitoring. Wearable technology’s transformative potential therefore lies not with the wearable itself, but with the real-time response to the data it collects.

As the healthcare ecosystem continues to shift to patient-centered care, a key consideration in designing the clinical trial of the future is the ability to make the process highly responsive and seamlessly connected to the patient’s every-day life. Currently the clinical trials process is inconvenient for participants; both in terms of time spent travelling to and from the trial location, and the time required to log physiological and drug reactions. Wearable devices can reduce the number of times patients need to go to a clinic and can provide a better, fuller picture of physiological data needed to measure a drug’s impact. Medidata and Garmin are collaborating to use Garmin’s activity tracker —the vivofit — in clinical studies. The vivofit measures steps taken, calories burned, and hours slept to capture patient data during clinical trials 24/7, without the need for clinic visits. The clinical trial data it collects is integrated with the Medidata Clinical Cloud repository that includes information such as vitals, medical histories, laboratories, and adverse events. Used in this way, wearables not only lead to increased data, but through remote monitoring, can reduce interruptions in a volunteer’s day.

Clinical trials are often criticized for not being sufficiently patient-centric. Innovating through the use of wearable devices can address this challenge by streamlining the process and creating greater patient engagement. The Clinical Innovation team at Eli Lilly recently offered a glimpse into the future through an interactive and immersive clinical trial simulation for Stanford Medicine X conference attendees. The team highlighted design considerations for remote clinical trials, as well as working prototypes for a mobile patient trial app, provider trial app, and a medical-grade biosensor. In order to contextualize and make data actionable, the design team at Eli Lilly is working on a closed-loop system that triggers an alert when certain metric points are activated, thereby allowing for real-time adjustments to be made.

Making the clinical trial process more convenient and connected through wearable devices could potentially explode the sample size of clinical studies, not just numerically, but also in terms of diversity – gender, ethnic, geographic, economic. We might then begin to get a more stratified picture of individual variation; hard to do with current methods of traditional clinical studies. The large uptake of Apple’s ResearchKit (an open source software framework for app development) on its release earlier this year, signals a greater willingness to take part in research when tools are designed to make participation easier. Within a day of ResearchKit’s launch, 11,000 volunteers signed up for a Stanford University cardiovascular trial; an unprecedented uptake. At the time, Stanford said it would normally take a national year-long effort to get that kind of scale.  However impressive these numbers are, a large test sample only matters if there are enough quality results. Furthermore, diversity is compromised if lower socioeconomic populations are excluded through restricting sampling to people that are iPhone users. If the very people who tend to be most affected by chronic diseases are excluded, research will be skewed toward a demographic that is markedly different than the one typically affected by the target disease. Still the future looks hopeful. With any study, there are challenges around how representative the study cohort is. The expectation is that smartphone apps, wearable devices, and biosensors can make the clinical trials process more responsive to volunteers, expand recruitment, and make the data source richer.

Challenges and Opportunities

The clinical trial of the future will increasingly take place outside the walls of the clinic. Tailored to the patient’s lifestyle, wearables can lead to increased patient engagement and ultimately bigger and smarter data. Trial volunteers will wear a device that continuously measures their activity and provides a complete picture of movement without having to disrupt their day. Physicians and researchers will have access to a much richer, more objective data set, thereby providing a real-world, real-time measure of patient physiology and how a drug affects quality of life. This will allow us to have a more holistic view of the patient than we have ever had before.

Wearables are emerging as a tool for creating a more responsive and efficient clinical trial process. At the same time, wearable devices can increase the volume and speed of data collection through a more seamless collection of large quantities of longitudinal physiological measurement data. This approach to clinical trial management promises to significantly change how trials are conducted and increase the value of trial data. However, the challenge lies in how to unlock the data’s value to make it more actionable, contextualized and meaningful. How will researchers turn the sheer volume of data they collect into quantifiable safety and efficacy measures and endpoints? At this point wearables don’t yet offer the type of medical or diagnostic-quality data that’s necessary for most clinical trials. Researchers must ensure not just accuracy of data, but also be able to evaluate and identify the data pertinent to the clinical trial outcome. For instance, a sleep monitor on its own cannot contextualize the reason why people wake up – they may be having an asthmatic attack, or a bad dream, or simply need the bathroom, but the monitor registers each of these instances as the same event. Or take the scenario of a trial participant who transfers his/her activity tracker to someone else – what would happen to the validity of the data in this case? How can researchers handle patient device use and adherence variability?

Stakeholders must work together to determine how to best deploy wearable devices to patients, define standard use, mitigate variability of use, link the data from these devices to traditional clinical data, account for data collection in a non-controlled environment, and maintain privacy and data security. With much work still to be done to scientifically evaluate the real impact of wearables on clinical trial data, regulatory compliance in collecting clinical data outside of a controlled research environment is an on-going challenge. Wearables offer an opportunity to disrupt the clinical trial process, leading to a radical redesign of patient-centered clinical trials.  For now, we must learn to balance the hype which surrounds wearable technology with the operational and design challenges posed by standardizing and controlling the data collected for use in clinical trials. Focusing on these challenges will help to ground wearable technology in the reality of what is achievable, while the industry takes its first steps on the path toward designing next-generation clinical trials through wearables, and ultimately new ground-breaking drugs and treatments.

An Oncologist’s Perspective on Clinical Trials

(Editor’s note: This article is in 2 parts. This is Part 1 (go here to read Part 2) and consists of an interview of Dr. Anita Wolfer, Senior Oncologist and Head of Unit in Oncological Research, Lausanne University Hospital (CHUV). The interview was conducted by the “Indomitable” Christine Bienvenu, breast cancer patient, avid patient advocate and board member of the Patient Empowerment Foundation, our sister organization under development in Europe. And please, don’t be concerned that this is an interview with a European oncologist. You will be surprised to see that the issues, thoughts, concerns of patients and doctors are the same. These issues are worldwide!)

Great progress has been made today in immunotherapy and targeted therapies – especially in cancer research – thanks to patients having access to clinical trials. It is crucial that patients learn about their options.

Interview With Dr. Anita Wolfer

The Indomitable Christine Bienvenu

The Indomitable Christine Bienvenu

Christine Bienvenu (CB): How do clinicians learn about clinical trials?

Dr. Anita Wolfer (AW): It depends very much on where they’re working: Doctors in university hospitals are constantly informed of clinical trials. Their peers outside the hospital environment are not, though: It’s up to them to actively find clinical trials and stay informed.

 

CB: Here in Switzerland, are there formal protocols in place for spreading information about clinical trials?

AW: In terms of the medical system, there aren’t any formal protocols on doctors being up to date on clinical trial options. I think it’s important that university doctors take it upon themselves to keep their non-university environment peers informed. Often, unfortunately, those oncologists working outside the hospital environment only think of clinical trials when conventional treatments have failed. For researchers like us, it’s more second nature to turn to them for treatment options.

Here in Switzerland, the “Réseau Romand d’Oncologie” (Western Switzerland’s oncology network) centralizes all the information about clinical trials, and keeps it updated. For the new Swiss Cancer Center Lausanne (SCCL) opening in 2017, its director, Prof. Coukos’ vision is simple: All information – clinical trials, research, collaboration, and participatory medicine – should be accessible to patients and professionals alike.

 

CB: When and why do clinicians talk about clinical trials to their patients, and how do you view the patient’s role in trials?

AW: Often today, oncologists will only talk to a patient about clinical trials if they see that there’s a direct benefit to the patient. But in my view, it’s important to inform the patient of the clinical trial, regardless so that they too can look into the application process. In an ideal world – and I say this as an oncologist and clinical researcher – there would be a clinical trial for every patient who walks through our doors.

As for the patient’s role, I’m a firm believer that sharing is building in this profession. Patients are crucial in this process: No-one knows their bodies better than they do. The way I see it, any patient of mine gives me the opportunity to learn. I don’t want to waste that.

 

CB: What obstacles do clinicians face in conveying clinical trial information to their patients?

AW: Unfortunately, some oncologists are afraid that university doctors might “steal” their patients, so they don’t readily refer them for fear of losing income for their own hospital. With patients being so closely followed during the clinical trials as well, this is comforting: Often, they’d rather not go back to their ‘regular’ oncologist. In my view, it’s a shame to look at it that way: If there’s a relationship of confidence and trust with their primary oncologist, if patients know they will get all the necessary information, they’ll be more inclined to stay with their respective ‘regular’ oncologists. To be brutally honest, my feeling is if an oncologist is upset about a patient seeking a second opinion, then maybe it’s time to find a new oncologist? It happens in the medical profession: I’m not immune to it – no-one is. But it shouldn’t be an issue… Just like in any relationship, if the doctor/patient relationship isn’t working out for the patient, he or she has every right to move on.

 

CB: In your profession, how important is mindset – in both the patient and the doctor or clinician?

As in any profession, or with any patient or co-worker, there are always those who are willing and excited to go the extra mile. If the mindset to do so isn’t there, there really isn’t much that either a patient or an oncologist can do in terms of moving forward. A pro-active mindset is crucial.

 

CB: In the same vein, how important is mindset in clinical trials, then?

AW: Being convinced about the clinical trial is also very important – not only for the patient, but for the doctor. A well-informed doctor means a well-informed patient. Speaking for myself, I’m constantly on the lookout for the best treatment options for my patients – even if it’s a clinical trial outside the CHUV. Why wouldn’t I? It’s about moving forward in cancer research, not about being territorial with knowledge.

 

CB: What role, for you, does the sharing of information and access to clinical trials play in patient mindsets?

AW: Armed with information, most patients are willing to be a part of trials – even if it isn’t one they had specifically hoped for. Time and again, we’ve seen how patients who participate in clinical trials usually have better outcomes than patients who don’t. Beyond the obvious rigorous monitoring, the crucial element here is that the patients feel more responsible for, and engaged in, their care. What strikes me, time and again, is that clinical trials offer hope. And while not every clinical trial story is a positive one – with frustration and heartbreak often integral to the process – hope is a crucial element and great motivator.

 

CB: Getting into clinical trials is no small feat. What improvements, if any, would you suggest? Can patients be better-informed about clinical trials?

AW: In an ideal world, there would be a clinical trial for every patient. One of the objectives of the CHUV oncology department is to have a portfolio of trials so that there are alternatives for every patient. And despite limited resources, the department is working hard to open up a maximum of number of trials. Also, with the SCCL opening up in Lausanne, more research funding is coming in, and more specialised oncologists are coming on board.

 

CB: What for you is a key component of a successful patient/clinician or doctor relationship?

AW: Ultimately, it’s about trust, confidence and collaboration. And going back to your previous question, if patients feel they’re being fully supported by their oncologist, they’ll return to them – university hospital setting or not. To me, it’s extremely important that patients take the necessary steps to establish the relationship of trust that they seek.

 

CB: What feedback have your patients given you about their experiences in clinical trials?

AW: Some patients will say outright that they’re not interested. But the vast majority – I’d say 70-80% – are willing participants. So far, I’ve only ever had one patient tell me she wasn’t happy with a clinical trial. For most, it goes beyond participating for their own benefit, per se: it’s about being part of a greater cause and helping medical science advance. Patients are genuinely altruistic. What is clear, though, is that it’s a team effort that involves the patient and the medical community.

 

CB: Where can patients find information about clinical trials?

AW: There are a number of great resources out there. In no particular order, I can suggest the Swiss Group for Clinical Cancer Research (http://sakk.ch/en/) or Clinical Trials (https://clinicaltrials.gov/) which is a service of the US National Institutes of Health that lists all the studies being done in all 50 US States and in 190 countries.

Here in Switzerland, there are obviously the Lausanne University Hospital (CHUV: http://www.chuv.ch/) or the Geneva University Hospital (HUG: http://www.hug-ge.ch/) websites. Experience has taught me that the university websites are sometimes a bit outdated, but patients can send emails directly to oncologists there and should get an answer.

 

CB: Any parting words of wisdom?

AW: Patients never doubt themselves in asking questions. There is no such thing as a stupid question. If a patient isn’t having his or her questions answered, he or she has every right to find someone who will! Questions are crucial: They lead to greater understanding, knowledge, and progress.

Also, it’s important to remember that in Clinical Trials, limits have to be set to be able to provide realistic results. Make the criteria too broad, and it becomes difficult to show a trial’s effectiveness. With immunotherapy, clinical trials broaden patient eligibility. Granted, a patient needs to be healthy enough to be able to benefit from a trial, so if for example a patient is in palliative care, they wouldn’t be eligible – unless, of course, the clinical trial is in palliative care.

The National Cancer Institute’s (NCI) “10 step guide on how to find a cancer treatment trial” helps patients better understand what clinical trials are all about, how to talk to their doctors, and know what questions to ask, visit: http://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide?cid=tw_NCIMain_nci_Clinical+Trials_sf39211784

Clinical Trials and Young Cancer Patients

Few Cancer Patients Enroll in Clinical Trials

It is well known that very few people with cancer actually enroll in clinical trials. This, for a myriad of reasons, including misconceptions, logistics, awareness, eligibility and fear.

Many patients lack awareness of what a clinical trial actually is, what it is for, and what is being tested.

Many healthcare professionals do not fully communicate information about clinical trial availability and participation when discussing treatment options with their patients.

Patient Advocacy organizations and other healthcare groups are trying to get the word out about clinical trials as a good treatment option and raise awareness. But progress is slow.

There are myths perpetuated about patients being “guinea pigs” in medical trials, or about patients being given “placebos” in the place of cancer medication. These myths need to be addressed and there are organizations and websites that do offer general answers to patient questions about trials. Patient Empowerment Network offers a FAQ page that addresses common questions about clinical trials. And ProjectInnovation offers a special section in their resource guide called, Debunking Common Myths About Cancer Clinical Trials.

Besides a lack of awareness and perceived misconceptions about clinical trials, there are logistics and eligibility obstacles that prove to be just too overwhelming for many patients. These obstacles are being addressed by many organizations, but again, progress is slow.

Do Younger Cancer Patients Experience the Same Preconceived Ideas About Trials?

Most cancer patients are older. What about the younger cancer patients? Do they feel the same way? Do they have the same misconceptions and the same fears? Do they also suffer from the same lack of awareness? Are they also overwhelmed by logistics and eligibility issues?

These are questions that StupidCancer and Bristol-Myers Squibb are trying to answer.

StupidCancer, founded by Matthew Zachary, is the largest charity that specifically focuses on young adult (age 15-39) cancer. There are 72,000 cases diagnosed each year of young adult cancer. This group suffers from a lack of awareness and understanding from the community around them. StupidCancer helps by building awareness, offering support and resources and generally getting the word out through advocacy, research, outreach, mobile health and social media.

Iamnotatrial Project

StupidCancer, in partnership with BMS, is embarking on a project called “iamnotatrial” that will feature young people between the ages of 15 and 44 years old who have completed a clinical trial in one or more of 15 cancer types. These clinical trial participants will be featured in a series of short videos that will tell their stories and relay their experience with clinical trials and will hopefully help build awareness and interest in clinical trials within the younger patient community.

When interviewed, a representative from StupidCancer explained that the goal of the iamnotatrial project is that by showing real patients and survivors telling their story in their own way, by video, that they can channel the energy of these patients and send it towards other patients who are taking action and looking for trials, enrolling and asking questions.

It is the hope and intention that viewers of the videos will become more aware that trials are a viable option, that there is diversity (gender and ethnicity) in trials and that there are many reasons to participate in trials- to help yourself as well as to help others.

Patients Helping Patients

Cancer Patient

Empowered Patient at a recent Town Meeting for Cancer Patients

Patients learn from patients like them. Patient stories are a powerful way of getting the message across. We are anxious to see these videos and champion their cause. We are anxious to help SupidCancer get the word out about clinical trials to their younger cancer audience.

Talk to your medical team and consider a clinical trial. It could be the best treatment option for you.

How Do I Enroll in a Clinical Trial?

Oftentimes when we hear the word “cancer,” we hear nothing else. Our brains stop processing information. We think we’re going to die, that there is little or no time to weigh options and/or get our affairs in order.

Fortunately, that last part the vast majority of the time isn’t true. We DON’T have to rush into anything. We DO have time to weigh our treatment options. And for many patients, those options can include enrolling in a clinical trial.

What is a clinical trial?

According to PAF, the Patient Advocacy Foundation, clinical trials are research studies in which we patients can help doctors find ways to improve cancer care.

There are several types of trials

  • Treatment: to test a new drug or approach to surgery
  • Prevention: to test new approaches with medicine, vitamins, minerals to help lower the risk of developing certain cancers
  • Screening: Best ways to detect cancer early
  • Quality of Life: Explore ways to comfort, quality of life for patients

Why participate in a clinical trial?

Through clinical trials, doctors and researchers find better ways to prevent, diagnose and treat cancer. Patients can benefit by receiving cutting-edge care or emerging medications. Rarely are placebos, or fake medications, used in clinical trials. Patients for the most part are being given the current standard of care or the new treatment, to determine the following:

  • Phase   I: Is the new treatment safe?
  • Phase II: Does the new treatment work?
  • Phase III: Does the new treatment work better than the current one?

Is a clinical trial right for me?

There are risks and benefits. A good place to start making an assessment is with your physician. Often, we’ll hear about a clinical trial from our doctor. However, you don’t have to have your doc’s OK to enroll in a trial, and it’s key to determine which trial is right for you.

While there is no one source to learn about all cancer clinical trials, you can break it down into clinical trial lists and matching services.

Lists:

The National Cancer Institute (NCI): 1-800-4-CANCER (422-6237 NCI sponsors most government-funded trials. You can search by the type and stage of cancer, by the type of study (treatment or prevention) or by zip code.

The National Institutes of Health (NIH):   NIH database is larger than NCI but not all trials are cancer studies

CenterWatchCenterWatch provides a list both of industry-sponsored and government-funded clinical trials for cancer and other diseases.

Private companies: Pharma or biotech companies may list studies they are sponsoring, either on their websites or through a toll-free number. You can search a company with the words ‘clinical trials’ in the search. If that company is conducting trials, it will appear in your search. For example:

pfizer.com/research/clinical_trials

amgentrials.com

abbviephase1.com

You get the idea.

As for those clinical trial matching services, each one works differently. Some may charge a fee to the trial sponsor. It could impact the way studies are ranked or presented to you. We suggest you start with the free sites. Sources include:

The American Cancer Society Clinical Trials Matching Service:    1-800-303-5691  ASC works with a company called Eviti  to connect patients with trials. It’s free. It’s confidential. It’s reliable. The lists are updated daily, and it allows patients to contact health care providers running the studies. The website also explains how to determine if you are eligible for a trial, if a trial is right for you.

EmergingMed:  1-877—601-8601  Also free, confidential and reliable for cancer patients seeking a trial.

Various organizations have partnered with EmergingMed and offer widgets that link to the EmergingMed trial finder. For instance, both the sites below link the viewer to the EmergingMed clinical trial finder:

www.oncolink.org/treatment/trials.cfm

www.lungcanceralliance.org

There is a wealth of information here. But you don’t have to become a Medical Doctor to digest and evaluate it. Start with your physician. If he or she doesn’t have enough information, choose a website or two on this list to navigate for information about trials. That’s what I’ll be doing should the day come that I need additional treatment. We are our best advocates about what’s right for us and when.

(We want to help you if you are considering a clinical trial. Please look at our FAQ and Clinical Trial Toolkit pages and browse our Patients Helping Patients blog for articles on clinical trials)

Clinical Trials

 

Clinical Trials 2.0: Reinventing Research For The Social Age

Clinical research is changing. No longer the sole preserve of clinicians and researchers, the Internet and new digital technologies are reinventing the way in which patients take part in the clinical trials process.

In the past decade there has been a revolution in how patients access health information. The Internet is increasingly the first port of call on our health-seeking journey. According to Pew Research Center’s Internet and American Life data, one in three U.S. adults have gone online to figure out a medical condition; 34% of Internet users have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog; and 18% of Internet users have gone online to find others who might have health concerns similar to theirs.

“Clinical research” is among the most-searched terms on the Internet; yet every year hundreds of trials are delayed or abandoned because they can’t recruit enough patients. Poor rates of trial recruitment are a major obstacle to the successful and efficient completion of clinical trials. Insufficient recruitment of study participants may result in losing the statistical power of a predictive conclusion, as well as prolonging the time it takes to get the trial drug to market. Oncology trials in particular are failing to meet enrollment goals, with most delays in conducting trials stemming from recruitment. 85 percent of cancer patients don’t know trials are an option. 55 percent of clinical oncology sites fail to get a single patient because they simply can’t find them and one third of trials fail to recruit a single patient1.

Given that enrollment into a clinical trial is frequently the best treatment option for patients with cancer, how might we make more patients aware of the benefits of clinical trials? Combining the power of new technologies with social networking and patient activation is our best chance at galvanizing the process of patient recruitment, and perhaps even an opportunity for us to completely reinvent the process of clinical research itself.

The world-wide web has opened a window to the world of clinical research. With the click of a mouse, we can now access information on the latest trials, download medical information to our portable devices, connect with researchers in real-time, and find other patients with the same condition. Dedicated websites such as the U.S government’s ClinicalTrials.gov site, and the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), help patients easily find information on clinical trials. The launch of these sites represented a paradigm shift in clinical research; information that had once been closely guarded is now available to all. Some other note-worthy websites include The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to educating and informing the public about clinical research; and clinical trial recruitment sites, such as ClinicalConnection, TrialReach, EmergingMed and CureLauncher which exist to match eligible patients to appropriate trials. A new digital platform Cure Forward uses a patient’s uploaded genetic sequencing to connect cancer patients to clinical trials. The site, which is currently in beta, also offers cancer patients more information on the mutations and treatments available in “gene stories” specific to their genome.

Mobile applications can be downloaded from the Apple and Google Play Stores to give patients real-time access to current information about cancer clinical trials. This is opening up opportunities for better medical treatment and care, and allows those in regional and remote areas equal access to clinical trial information.  Some sites, such as the Novartis Clinical Trials website provide users with an interactive tool for finding relevant trials taking place near their location. A GPS search function allows users to see all the trials taking place in their country by location. For those looking further afield, the Novartis site features a global search function that displays clinical trials taking place in any country.

Popular social networking sites such as Twitter, Facebook, and YouTube are being used, alongside dedicated social media patient communities, to raise awareness and encourage wider participation in clinical research. The TrialX site encourages patients to send a tweet to @trialX, preceeded by “CT” describing the type of clinical trials they are seeking. Dr. Susan Love Research Foundation’s Army of Women Program (AOW) taps into the power of its social networks to mobilize research into the causes of breast cancer.

 

“The word Army, which means a large group of people united for a specific purpose, quickly and clearly describes who we are. The image of us all joining in a virtual Army to get this done is a powerful one” – Dr. Susan Love Research Foundation.

 

 

The traditional methods of advertising clinical trials through print media, brochures or poster displays, meant geographic limitations narrowed the pool of potential recruits. Using popular social networking sites, researchers can now accelerate the recruitment process by extending their social reach to take in a global pool of potential recruits. According to US hospital group, Mayo Clinic, social media is especially effective at recruiting patients for its studies into rare diseases. Social media and online networks could help researchers assemble large and demographically diverse patient groups more quickly and inexpensively than traditional outreach methods. “Patients with rare diseases tend to find one another and connect because they are searching for information and support,” says Mayo Clinic’s Marysia Tweet, M.D. “Studies of rare diseases often are underfunded, and people with these conditions are quite motivated.”

One such motivated patient is Katherine Leon, an SCAD (spontaneous coronary artery dissection) survivor, who was determined to find the cause of her disease, and prevent it from happening to others. At the time of her diagnosis, SCAD, a traumatic cardiac event that affects fewer than 200,000 Americans, was a poorly understood and under-researched condition. Physicians had no clinical studies on which to base treatment plans. Leon connected with fellow SCAD survivors through social media and used their collective voice to launch research at the Mayo Clinic. The study recruited 18 participants in less than a week, six more than could participate in the initial study of 12 patients. This rapid enrollment of participants through social networking served as proof of concept for future research studies to harness the power of highly-motivated patient communities. Leon credits social media as a key research accelerant. “Social media absolutely gets the credit for making scientific study of SCAD possible” she says. “In 2003, my cardiologist told me I would never meet another SCAD patient. It was just too rare. Today, I “know” more than 1,000 fellow survivors thanks to Inspire, Facebook ‎and Google. These patients are connected to the clinical trials immediately — at hello!”

Harnessing this dynamic combination of new digital and mobile platforms, social media, and activated patients offers an unprecedented opportunity for patients and researchers to find each other with greater speed and precision, which in turn can speed up the process of recruitment to clinical trials.

Peer-To-Peer Education

The ability to engage interactively through social media further enhances the benefits to patients. Reading information in a brochure doesn’t compare to the ability to interact and ask questions in a social networking site. What is it really like to take part in a clinical trial? Would you need to travel? Will it incur any personal expenses? What kind of side-effects might you have? Trial sponsors can respond in real-time to these questions, thus speeding up the recruitment process. In addition, patients already enrolled on the trial, can provide personal insight into what is involved. One patient, who has participated in two Phase 1 clinical trials, said that he was motivated to sign up for them, by reading others’ stories online. Hearing about the experiences of others who had participated and “come out the other side” encouraged him to take part.

Sometimes there can be an open sense of distrust about the nature of clinical trials – a fear on the part of some that they will be treated as a “guinea pig”. For patients who may be wary of research agendas (particularly when pharma-led) peer-to-peer education is a vital ingredient in building trust and confidence in clinical trials. Patient advocate, Stacey Tinianov believes “there is great value in patients and caregivers leveraging the connected platforms to educate themselves on the benefits and realities of clinical trials. Learning patient to patient is often more accessible for a variety of reasons, not the least of which is a certain trust”.

Moreover, social networking has the potential to empower patients and care-givers with a greater sense of control. All too often, patients who face serious illness can feel isolated and powerless; joining an online community can help enormously. By exchanging coping tips, offering encouragement and support, and sharing information on the latest clinical research, patients feel a greater sense of agency. Breast cancer survivor Diane Glassmeyer, took part in a Sierra-Stanford study of the effectiveness of support groups conducted via online video. The randomized clinical trial was designed to help researchers determine whether this type of video-mediated support group improves the well-being and quality of life of breast cancer patients who live in rural areas. Glassmeyer described the Skype Support Group as “an amazing experience to be able to see and talk to everyone in the group each week from all over the state”.

The role of the care-giver must not be overlooked in peer-to-peer support. Half of health information searches within the U.S. are on behalf of someone else. In the case of late stage oncology, or a paediatric trial, the caregiver’s involvement is imperative. We need to focus more on establishing communication and maintaining an on-going relationship, not just with the study participant, but with all involved in care-giving for the patient. Patient advocate, Andrea Borondy Kitts, a care-giver for her husband with lung cancer, says: “For the patient (my husband did not go on-line but I did) it was great to have technical help and sharing of latest research. I found out about Lucanix on the Inspire website and pursued it. When I needed to help my oncologist with the process of getting FDA approval for individual patient compassionate use, one of the Inspire members had the whole process documented and shared it with me”.

When Borondy Kitts’ husband was considering a clinical trial, she was able to get information from people with lung cancer about their experience, including side effects, with an experimental drug.  “When my husband had horrible side effects to his supposedly gentle chemo in Phase 3 clinical trial,  (Alimta /Pemetrexed), I found out from social media that many others had similar experiences and I also got tips on how to manage the side effects. My oncologist did not have enough patients in the trial to have observed these effects”.

 ePatient Reported Outcomes

Capturing Patient Reported Outcomes electronically (ePRO) through the web or mobile devices, offers a way to interact with trial participants, while also capturing critical data. Although patients for the most part face little or no restrictions on reporting their outcomes via social networking sites, there are some concerns about how this might affect the trial’s validity. Patients self-reporting on their trial treatment online and comparing notes with others may potentially jeopardize the trial. The exchange of personal experiences whilst enrollled in clinical trials can lead to patients (or any researchers on the same social network) to inadvertently “unblind”* themselves, leading to knowledge of treatment allocation. Concealment is crucial for unbiased reporting of results, and disclosures by one patient might unintentionally distort another patient’s awareness of their own symptoms, potentially skewing data reporting and potentially invalidating study results. The intersection of free speech, social media, and clinical research is still unchartered waters. Borondy Kitts, believes that while guidelines can be implemented to safeguard data integrity in a blinded trial, “for unblinded trials there should be very few limits on what can be shared.”

Patients Are Doing It For Themselves

The communication process which traditionally flowed from pharmaceutical companies to physicians to patients has been transformed by social media. Patients, who have traditionally relied on their doctors for information about the latest clinical research, are now realizing that information may be more readily found in their online patient communities. After she progressed following chemotherapy and radiation, Janet Freeman-Daily, a lung cancer survivor, took it upon herself to do her own research.

*A blinded study is a study done in such a way that the patients or subjects do not know (is blinded as to) what treatment they are receiving to ensure that the results are not affected by a placebo effect (the power of suggestion).

She found a molecular testing trial listed on ClinicalTrials.gov, and contacted trial sites until she found one accepting patients. The University of Colorado Cancer Center (UCCC) agreed to test her existing biopsy samples. Unfortunately, all her tests were negative.  However, she learned about more options online.  “Another patient told me I fit the profile of patients who had the ROS1 translocation,” said Freeman-Daily. “I was relatively young, had adenocarcinoma, was never a smoker, and tested negative for the three most common mutations.  He told me about the ROS1 trial, which he was in, and sent me the journal article with initial results as soon as it was published. However, my home hospital had not heard of ROS1, and did not know how to test for it.”  After she progressed following more chemo and radiation, Freeman-Daily contacted UCCC again and learned they had recently developed a test for ROS1.  This time her tissue tested positive, and she entered the ROS1 clinical trial in Denver.

Kathi Kolb describes the process of searching for a clinical trial after her diagnosis of cancer: “I searched the database of the National Cancer Institute and found a Phase 2 clinical trial to test a new medication to treat cancer-related fatigue in people with breast or prostate cancer. I had been doing a lot of research on the subject because I was suffering from horrible fatigue myself. Once I found a trial that fit and was close enough for me to get to, I followed the links provided and researched the cancer treatment center where it was taking place, as well as the clinicians in charge of the study. I was able to make initial contact with them by email. It was a really good experience overall.”

Janet Freeman-Daily, Kathi Kolb, Andrea Borondy Kitts, and Katherine Leon are part of a growing number of ePatients, empowered by the Internet and emerging new technologies, who are leveraging their online communities to drive and support the research agenda. From providing input into study design protocol, to raising awareness of the value of clinical trials and recruiting trial volunteers, patient influencers play a key role in accelerating the new research paradigm. AnneMarie Ciccarella, a patient advocate who serves on the Love Foundation Army of Women (AOW) Scientific Advisory Committee, believes patients have a valuable role to play in trial design. “The thing that interests me the most is trial design and having patients part of that process” she said. “Some grants require a patient advocate on the proposal. In some cases they are actively involved in the study design; in others, the researchers scramble to find an advocate before the submission deadline. I’ve participated as an advocate on a funded grant, possibly at the top of the list of things that mean the most to me. It’s about bringing patients and PIs [Principle Investigators] to the table when the questions are being formulated – a step ahead of actual trial design”.

The Future Is Social

 Ciccarella also serves on the advisory board of CureClick, an online platform which uses the power of crowdsourcing to share clinical trial information. As part of a group of key patient leaders, she helps recruit trial participant across all diseases. This new model of leveraging trusted patient leaders to educate their online communities about the benefits of clinical trials can do much to improve trial recruitment goals. CureClick ambassador Debbie Woodbury, explaining why she joined its advisory board, said: “I started working with CureClick early this year and serve on its advisory board because I feel that too often cancer patients find themselves in the curious situation of having too much, and too little, information. Many patients I’ve spoken to are overwhelmed with treatment decisions, and yet receive little to no information concerning clinical trials. The beauty of CureClick is the ease with which plain language information is shared peer to peer on social media, resulting in greater participation. It’s a win-win for everyone and I’m proud to be a part of it”.

The need for a faster and more globally scalable approach to trial recruitment, planning and design, is clear. To address challenges such as public awareness and understanding of clinical trials, increased competition for patients and decreased effectiveness of traditional advertising, requires new solutions. Social media are a key part of the solution. Social media offers patients greater accessibility and convenience of communication and information. For researchers, social media offers a unique opportunity for innovative trial recruitment modalities, increased efficiency and accelerated research outcomes. People are social creatures by nature; harnessing our innate desire for connection, to new information, social and technology platforms is the best chance we have to drive the next generation of research forward.

Refs

Malorye A. Can web 2.0 reboot clinical trials? Nature Biotechnology 27, 895 – 902 (2009).