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Clinical Trials – Patients ARE the Pioneers

Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Auroro, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.


“The pioneering spirit is less about thinking up new ideas as ridding ourselves of dogma and old habits that hold us captive in thinking.” Bertrand Piccard http://bertrandpiccard.com/home

Profound. Who wants to be captive in their thinking? No one I can name. Especially in the world of healthcare. Medical sciences are far surpassing dogma in many aspects of delivering care to patients – in technology, in documentation, in processes and structure, in diagnostics, in pharmaceuticals and other interventions such as surgical techniques all the way to preventative care. Some diseases have been eradicated entirely, others are manageable and have become chronic rather than life threatening.

It is invigorating to have even a small part in innovations with the potential to alter and improve the landscape of health and well-being. In last week’s broadcast of Mythbuster’s #3 – Do Patients Have a Voice While Participating in Clinical Trials? Our host, Andrew Schorr brought up the notion of being perceived as a pioneer in cancer treatment with each of our respective roles in clinical trials. Our panel was comprised of an oncologist and a clinical trial navigator (a resource who pairs patients to relevant trials)and myself, a patient advocate and participant in multiple clinical trials.

One trial in which I participated led to the provisional release of a therapy added to front line treatment for Ovarian, Fallopian Tube and Primary Peritoneal Cancer who test positive for either the BRCA 1 or 2 inherited genetic mutations. Addition of the oral medication researched has since shown astounding results for patients with these forms of cancer that prolongs disease free progression an average of 19.1 months. https://www.lynparza.com/ovarian-cancer-treatment.html

I personally never considered myself a pioneer, but in this context, I suppose it fits. Without patients, researchers and oncologists exhausting every resource to identify what can extend our life or achieve a cure for incurable forms of cancer; how can we validate new inroads to treatment?  Regardless of how it is termed, I take great pride in participating in clinical trials to prove efficacy for patients of today and the future. Pioneer. Forerunner. Research Subject. Terms mean less  to me than the knowledge that if just one patient considers a clinical trial as a result of seeing our webinar, it is validation enough my involvement matters.

Shortly after the broadcast, I was talking to a new acquaintance at a gathering about the program and my personal experience with various clinical trials. As I detailed my journey for her, she asked a time or two, so “ALL you ever did was take experimental medicines?” Communication breakdown. But yet, I was quite happy she expressed her question in the way she had so I could clarify. My response was swift, “No. In actuality, in only one clinical trial was the medication ‘‘experimental’. Other than one, I was enrolled in only Phase 3 or higher trials where the medications were known to be effective, they just needed more data to understand dosage, frequency and when to use in combination with existing chemotherapy drugs to amplify the power of each.”

Despite being in multiple clinical trials, I have yet to achieve remission and the elusive cure for my form of cancer; yet, I still chime praise for each trial I’ve been enrolled in. I consider each an opportunity a peek into the future of cancer management. While I cannot claim certain things regarding my cancer as a result of clinical trials, each one has earned me quality time with loved ones or has been a bridge to a new treatment option not available to me were it not for the commitment of researchers, oncologists and patients worldwide.

When you view the webinar rebroadcast or in summation, my hope is that you will be receptive to clinical trials as an additional avenue available to you. Beyond our specific topic of whether patients have a voice in clinical trials, in our segment, our message is clearly that patients do retain their voice during a clinical trial. Of equal importance, collectively our outcomes and first hand experiences are an even more powerful voice chiming their merits. In many ways the patient voice is important not just during, but extends long past the time parameters of trials.

https://www.patientpower.info/event/myth-busters3

Clinical Trials Awareness Week 2017

The Coalition for Clinical Trials Awareness (CCTA) is hosting its 3rd annual Clinical Trials Awareness Week on May 1 – 7, 2017. CCTA’s mission  is to advocate for the creation of a federally sponsored public awareness campaign to increase the public’s understanding of the benefits of clinical trials.

This week is a time to raise awareness about the importance of clinical trial participation and recognize the individuals who have made new, innovative treatments a reality for patients worldwide – clinical trial researchers and participants. By shining a spotlight on these unsung heroes, we can raise awareness about the benefits of participating in a clinical trial.

Check out some of the events happening this week:

Can Digital Media Save Clinical Trials Tweetchat?

As part of Clinical Trial Awareness Week, A Coalition for Clinical Trial Awareness (@CCTAwareness) and @patientchat will be hosting a tweetchat on May 2nd at 1:oo pm EST. We will be participating and are inviting you to join us! #patientchat #CTAW2017

New to tweetchats? – Check out this guide we created.

Clinical Trials Mythbusters – LIVE Webinar

Are clinical trials only for patients who run out of treatment options? Watch online and ask our expert panel questions as they debunk common myths around clinical trial participation. Tune in to hear the patient perspective and expert advice for making decisions about clinical trials.

Tune in to learn:

  •       What is a trial and when should I consider one?
  •       What are common clinical trial myths?
  •       If my cancer center does not offer a trial, what should I do?
  •       How can I stay informed?
  •       Is there financial assistance to be in a trial?

Watch online on Tuesday, May 2, 2017 3:00pm EST for a 30-minute virtual webinar. You’ll also have the opportunity to get your questions answered by the panel. Send questions in advance to questions@patientpower.info.

Register HERE.

Clinical Trials Mythbusters SM from Patient Empowerment Network on Vimeo.

 

Patients as Partners Conference

We are pleased to announce that we will be attending our parter, The Conference Forum’s, Patients as Partners US Conference this March in Philadelphia, PA. We are looking forward to hearing from leaders in the industry, meeting with colleges, and learning how to incorporate the patient perspective.

The 4th Annual Patients as Partners US is the only conference putting the patient voice on the same level as industry and government in finding solutions to engage and empower patients in the clinical trial process. It is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum. Join us and  get 15% off using our discount code PEN15 >> http://theconferenceforum.org/conferences/patients-as-partners/overview/. We hope to see you there!

If you cannot attend, please follow along as we will be live tweeting this exciting event! (@power4patients) Tweet us and let us know what you are interested in hearing or learning about!

Register using our coupon code PEN15 for 15% off!

Patients as Partners Event History

When this question was asked to our Disrupting Clinical Trials (DPharm) audience seven years ago, no one raised their hand. Immediately we saw the need for a conference on service for patients in clinical trials. However, more importantly, we saw the urgent need for the patient perspective in driving a conference on collaborating in clinical research.

What Patient Research Taught Us

Patients taught us empathy not only with their disease, but with their lifestyle and struggles in finding and experiencing a clinical trial. In particular, we learned the need to:

  1. Understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint.
  2. Vastly improve the patient’s entire experience in a clinical trial.

If it were not for patient research, we would not have an event 100% designed for the benefit of the patient.

We look forward to seeing you at the 4th annual Patients as Partners US this March 2-3.

Register using our coupon code PEN15 for 15% off!

Patients in Clinical Trials or Patient Advocates Needing Scholarships,
Contact Us at service@tcfllc.org

Accredited by 

#Patients2017 organized by:

Please do not reply directly to this email. Contact onalee@tcfllc.org with any inquiries.

Event overview: http://theconferenceforum.org/conferences/patients-as-partners/overview/
Event press release: http://www.prweb.com/releases/2017/01/prweb14018129.htm
Event hashtag: #Patients2017
TCF Twitter handle: @ConferenceForum

 

MyLifeLine: Learn About Clinical Trials

Editor’s Note: This post was originally published here on MyLifeLine.org. The mission of MyLifeLine.org is to empower cancer patients and caregivers to build an online support community of family and friends to foster connection, inspiration, and healing through free, personalized websites.

Learn About Clinical Trials

MLL ACT

Why consider a cancer clinical trial?

What clinical trials can offer, from the care you receive to the impact you can make.

Clinical trials offer a chance to receive investigational medicines or procedures that experts think might improve the treatment of cancer. This important option is not limited to people who have run out of choices. In fact, there may be clinical trials for every stage of disease in dozens of cancer types. In this video, patients and doctors share their perspectives on why joining a clinical trial may be an option worth considering.


“To have the opportunity to go on a clinical trial for a patient is extremely exciting.” —Sandra Swain, MD; oncologist


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Concern:
I don’t want to be a guinea pig for an experimental treatment.
The Truth:
Cancer clinical trials are developed with high medical and ethical standards, and participants are treated with care and with respect for their rights.

Concern:
I’m afraid i might receive a sugar pill or no treatment at all.
 The Truth:Cancer clinical trials rarely use placebo alone if an effective treatment is available; doing so is unethical.

Concern:
Cancer clinical trials are only for people with no other treatment options.
 The Truth:Trials can study everything from prevention to early- and late-stage treatment, and they may be an option at any point after your diagnosis.

Concern:
I’m worried that I won’t receive quality care in a cancer clinical trial.
 The Truth:Many procedures are in place to help you receive quality care in a cancer clinical trial.

Concern:
People might access private information about me if I participate.
 The Truth:In nearly all cancer clinical trials, patients are identified by codes so that their privacy is protected throughout and after the study.

Concern:
I’m afraid that my health insurance will not help with the costs of a cancer clinical trial.
 The Truth:
Many costs are covered by insurance companies and the study sponsor, and financial support is often available to help with other expenses; talk to your doctor to understand what costs you could be responsible for.

Concern:
Informed consent only protects researchers and doctors, not patients.
 The Truth:
Informed consent is a full explanation of the trial that includes a statement that the study involves research and is voluntary, and explanations of the possible risks, the possible benefits, how your medical information may be used, and more. Informed consent does not require you to give up your right to protection if the medical team is negligent or does something wrong.

Concern:
I’m afraid that once i join a cancer clinical trial, there’s no way out.
 The Truth:
You have the right to refuse treatment in a cancer clinical trial or to stop treatment at any time without penalty

How to know if a cancer clinical trial is right for you.

There are many factors to keep in mind when considering a cancer clinical trial.

As with any important decision, it’s a good idea to think about the risks and benefits of joining a cancer clinical trial. This video encourages you to ask your medical team about all of your treatment options, including cancer clinical trials. Trial participants, doctors, and patient advocates explain the factors you’ll want to keep in mind as you consider your treatment plan.


“I’ve always advised patients…when the circumstances weren’t urgent, to take time to understand their disease and to evaluate the alternatives.”  —Sandra Horning, MD; oncologist and chief medical officer


What to ask your doctor(s)

Asking The Right Questions Keeps You Involved In Your Care

A cancer diagnosis is often overwhelming, and it’s sometimes hard to gather your thoughts and know the right questions to ask. This video talks you through some of the questions it will be helpful to ask about your cancer, your treatment options, your doctor, and about whether participating in a cancer clinical trial is right for you.


“Talk to your doctor and say, ‘Tell me my full options.’ Raise questions. Be a pain in the neck. That’s what the doctor is there for.” —Arthur Caplan, PhD; medical ethicist


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Rules And Procedures Are In Place So That You Will Receive High-Quality Care

Before a single patient can join a trial, many different experts must approve every detail of the study—from why it’s being done to how often patients should be monitored. Once the trial begins, more unbiased experts provide oversight to check that the rules of the trial are being followed and patients’ rights are protected. This video features doctors and patient rights advocates explaining the high standards by which trials are developed and run.


“I explain…that when they’re on a clinical trial, they’re going to be followed very closely by…specific guidelines.” —Daniel P. McKellar, MD; surgeon and Commission on Cancer chairman


Informed Consent Describes The Study Process, Potential Risks And Benefits, And Your Rights As A Participant

If you are eligible and decide to join a trial, you will be required to review and sign the informed consent forms. This can be an overwhelming process, but it is how you will learn all the details of the trial, including the potential benefits and the possible risks, and give your permission to be treated. This video features patients, doctors, and patient rights advocates who offer tips and insights to help you navigate the process of informed consent.


“When I received the stack of papers…it made me realize this is really serious. But then…it was actually a good feeling to know that this was not something that was being done lightly.” —Rose Gerber; trial participant


Information And Support Are Close At Hand

Because so many people have been affected by cancer, there are many reliable and helpful resources to help you through your cancer journey. In this video, trial participants and doctors help you find the people and resources that may be helpful in educating you about cancer clinical trials.


“The first thing is to hold on tight and be optimistic and to get very engaged and educated about your cancer.” —Jack Whelan; trial participant


Reliable Resources To Help Along The Way

First, talk to your doctor

Your healthcare team is the best source for information about your treatment options, including cancer clinical trials. There are many questions you’ll want to ask your healthcare team when you’re ready to discuss treatment options. Print this helpful Discussion Guide and bring it to your next appointment so that you don’t forget anything important. Record your answers on the form and keep it handy for future reference.


Where to find information about cancer clinical trials

These clinical trial resources will help you find trials that might be right for you.


Support services

These trustworthy sources provide assistance with trial-related costs, which may not always be covered by insurance.

Practical support

Financial support

Additional nationwide support organizations


Don’t go it alone

There are millions of people just like you who are ready to ACT against cancer. These organizations provide advocacy, information, awareness, fundraising opportunities, and a community of like-minded people touched by cancer.

A Patient Advocate Speaks Out About Clinical Trials

Obstacles and Progress in Clinical Trials

Laura Cleveland

Laura Cleveland is a 18 yr CLL patient, an impassioned patient advocate and a peer reviewer of late phase cancer clinical trials for the NCI Institutional Review Board (IRB), with focus on trial design, accrual issues, regulatory mandates and informed consent.

Cleveland has 12 years experience in designing, evaluating, and reviewing clinical trials, and I was interested to get her thoughts on the clinical trial process, obstacles that patients face and any recent progress being made in the clinical trial arena.

Obstacles to Clinical Trial Enrollment

It is no secret that clinical trials face accrual problems. Half of all phase III clinical trials close because of insufficient accrual with only 2% of cancer patients participating. In Cleveland’s opinion, some of the biggest obstacles are:

  • The myth that clinical trials are purely experimental and that the subjects are treated as “guinea pigs”. Cleveland explained that, in trials, patients are followed much more closely than they would be in normal treatment situations and that all standards of care actually evolved from clinical trials.
  • Logistics – Enrollment is often delayed due to eligibility criteria or rules and regulations concerning testing and screening.
  • Randomization and the fear of receiving “placebos” instead of cancer medication. Cleveland explained that placebos are rarely given in cancer clinical trials. When drugs are compared, the experimental drug is compared to the Standard of Care, She went on to say that there is even a push to remove randomization from certain trials and that there are currently single arm clinical trials available.
  • Cost – If insurance does not cover the costs of extra tests and doctor visits, it can be costly for the patient. There are organizations that help with these costs, but often the patient must bear the burden of significant cost outlay.

I asked Cleveland what the one thing is that industry/government can do to make the clinical trial process easier for patients. She had a very simple 3 word answer:

“Pay for it”

Progress Being Made in the Clinical Trial Process

When asked what progress had been made recently in the clinical trial process, including enrollment, navigation and process in general, Cleveland had several comments:

  • The patient materials are becoming more understandable and easier to read. The documents are being “translated” into plain language, the informed consent form is getting shorter and less complicated. Cleveland has been working with the National Clinical Trials Network on this for the past several years.
  • Patient-friendly clinical trial results are being published so that patients can read about these trials and understand them. Cleveland has been working with the Alliance for Cancer Clinical Trials on this.
  • Cooperative Groups have been working on ways to change the consent process and clinical trial protocols. These groups get together and discuss strategy to improve the whole clinical trial process to make accrual more attractive and patient-friendly. This is a slow process but encouraging steps are being taken. Cleveland said that patients are given a clinical trial “packet” that often, they do not understand. She further explained, “There needs to be a patient-friendly summary that the patient can read and easily understand before they even attempt to read the Informed Consent form. This summary needs to be in plain language and outline the clinical trial that they are considering.” Apparently, this type of summary exists for a few clinical trials, but it needs to be the rule rather than the exception.
  • Clinical Research and Clinical Trials need to be in the vernacular. They need to become everyday words and concepts. Social media is helping in this effort. Tweets and Facebook posts help with awareness. But there needs to be more effort in this direction. Possibly, clinical research staff could visit Middle School or High School and talk to the science or health classes about trials. Children can be great advocates of causes and could bring the word home to siblings and parents. Breast Cancer groups have done a great job for breast cancer awareness; they could really help by spreading the word about breast cancer clinical trials and clinical trials in general. Much, much more needs to be done in this area. Cleveland summarized,

 “As far as getting the word out about clinical trials, it’s just not there.”

In closing, Cleveland had several words to say to patients about self-advocacy.

“Get a second opinion! Seek out a specialist in the specific disease area that you have. Find out who is doing research in that area and contact them. Use all resources available to you. You must be your own self-advocate.”

Clinical Trial Process: A Physician’s View

Interview With Dr. Jeff Sharman

Dr. Jeff Sharman is Medical Director of Hematology Research at The US Oncology Network, one of the largest networks of integrated, community-based oncology practices in the US. US Oncology includes over 1000 physicians practicing at more than 350 sites in 19 states, and treats more than 750,000 patients annually. Dr. Sharman is also on the Patient Empowerment Network Advisory Board.

The US Oncology Research Network has enrolled over 60,000 patients in about 1,400 clinical trials so far. The website offers a trial finder that will connect you with a US Oncology practice near you that has clinical trials available.

Dr. Sharman is convinced that although research adds to a physician’s workload, it enlivens a practice and adds to productivity. In a video on the US Oncology website, Sharman says US Oncology found that physicians that recruit one patient per month on average are 70% more productive than their counterparts.

I asked Dr. Sharman several questions about the clinical trial process and he was kind enough to answer.

1. From the physician perspective, what are the 3 biggest obstacles in the clinical trial process?

“Regulatory oversight has become too burdensome.  In major academic centers and cooperative groups, it can literally take YEARS to open some studies – let alone accrue the study and determine the results.  Often the key scientific questions have changed before the study is executed and the results are no longer relevant by the time they are answered.  It is a case of “death by good intentions” to see such caution in clinical trials, but unfortunately, patients are dying while studies are acquiring the requisite signatures to get started.  In community practice, we are able to cut start up time to a small fraction of our academic counterparts, but the oncology practice environment these days makes it hard to fully engage in both clinical medicine and research.  Eligible patients are often not enrolled in clinical trials that are available at their own site because physicians are not able to slow down enough to connect the dots.”

2. What is the one thing that industry/government can do to make the clinical trial process easier? Why don’t they do it?

“Reduce the barriers to enrolling patients on clinical trials at the Medicare level and possibly even provide greater incentive to sites for quality research participation.  Medicare Advantage plans until recently had regulations that actually INCREASED the cost to patients to enroll on clinical trials.  Patients had higher copay (went from 10% to 20%) AND they lost maximum cap guarantee.  It was a powerful DISINCENTIVE to clinical trial participation.  That has been improved however Medicare is currently adopting numerous quality measures in reimbursement models to practicing physicians.  Research engagement could easily be included in these quality measures and would powerfully encourage participation.  Policies that are adopted by Medicare are often followed by major insurance carriers so there could be a spill over effect.”

3. Who are the major influencers in this arena? (This includes patients, advocates, industry, government and HCPs)

“Right now, virtually all power resides with the pharmaceutical companies.  They are the only entities with the budgets to sponsor clinical trials.  Government funding and grant agencies probably account for less than 10% of current clinical research in oncology.  Government could create tax incentives for pharmaceutical companies to provide research opportunities to investigators for more investigator initiated studies.”

4. What are the major positive changes that have been made to the clinical trial  process in the past 2 years?

“The agents used currently in clinical trials are based upon a far more detailed understanding of cancer biology than the cancer drugs of only 10 years ago.  With greater precision, drugs are often more effective with fewer side effects.  Furthermore, we are far more capable of understanding the unique biology of an individual’s cancer.  In the past, we might just call a disease by a specific name, but now we can often find the unique molecular heterogeneity within a single patients cancer.  This allows us to explore investigational therapies that may be unique to an individual patient.”

5. What is US Oncology Network doing in the way of clinical trial awareness for doctors and patients?

“Our network will enroll over 4000 patients to clinical trials this year alone.    US Oncology is a management organization for many practices and through thoughtful leadership enhanced the role of research within many practices.  US Oncology research has dramatically improved relationships with sponsors and sites to bring the best clinical trials to patients.  I could talk for hours on this.”

Thank you, Dr. Jeff Sharman and US Oncology!

Please discuss your treatment options with your medical team.