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).

 

 

 

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.

Patient-Selected Controlled Clinical Trials: A Valid Proposal

Lagging patient accrual numbers for cancer clinical trials has always been an issue. In a previous post, I mentioned several reports that showed that the current system of enrollment for clinical trials just isn’t working for patients, researchers or sponsors from pharmaceutical companies.

In the current issue of the ASCO Post, Jim Omel, MD and Karl Schwartz, MFA have written a great article proposing a new type of clinical trial: A Patient-Selected Controlled Trial.

The authors explain that this approach is not meant to replace the randomized controlled trial design “when it’s feasible and ethical to use it”. They suggest that it be used as “an additional tool to consider when comparing treatments for cancer, such as (but not limited to) when the compared interventions have very different risks, or when both treatment protocols can be used off-study.”

CityofHope0897The patient-selected controlled trial would let the patient decide whether to be randomly assigned to treatment or to choose the treatment arm they want to be in. Their decision would be based on their personal situation and, most often a detailed discussion with their physician.

This type of trial would most likely result in out of balance study arms. This shortcoming could be mitigated by factors such as the following:

  • This patient-selected design would be more attractive to patients, resulting in larger studies and faster accrual.
  • Statisticians may be able to apply methods to achieve balance – such as limiting accrual in the rapidly enrolling arms
  • Propensity scoring which can anticipate and account for confounding variables in order to adjust for bias may be used in this type of trial.
  • Study doctors can provide or capture the reason for choosing one arm or the other, thereby helping to interpret outcomes and to determine whether a larger study is needed.

and others.

The authors argue their case in part by saying, “We should not let the perfect be ‘the enemy of the good’ – that is, insisting on perfection can result in no improvement at all” In other words, isn’t it better to have a good, complete patient-selected controlled trial with a bias that can be mitigated than wasting time, energy and finances on a randomized controlled trial that has to be terminated because no one shows up.

The authors conclude,

We submit that the patient-selected controlled trial is clearly superior to any randomized clinical trial that is never started because it’s judged to be unfeasible, or to any randomized controlled trial that is terminated because of poor enrollment. What good is a statistically perfect well-designed randomized controlled trial if no one signs up? We hope and expect that the patient-selected controlled trial provides another way to do good science while practicing good medicine.”

Please read the full article here and comment!

 

 

Clinical Trials: Good, Bad & Ugly

Clinical trials for cancer patients can be a life-saving opportunity. But most clinical trials do not even finish due to lack of patient participation. Why is this?

One big issue is that many cancer patients do not hear about relevant clinical trials. Physicians often do not mention them because either they don’t know about them or because of time constraints. It takes a good deal to time to explain about a clinical trial to a patient and then to help walk them through the approval process and answer their questions. Many physicians do not have the time or the staff to do this. And often, cancer patients are too overwhelmed to inquire.

I asked Andrew Schorr, two-time cancer patient and founder of PatientPower.info, why he thought that more patients don’t know about clinical trials when they are first diagnosed with cancer. Schorr answers,

“When patients are just told they have cancer, they feel afraid and alone. They rely on their doctor for guidance and don’t think of looking elsewhere for information. It does not occur to them to think of participating in a clinical trial for treatment.”

I asked Jim Omel, a 13+ year myeloma survivor and retired family physician who has participated in NCI (National Cancer Institute) peer reviewed research and who is a patient advocate working withThe Alliance for Clinical Trials in Oncology,  about his thoughts on why more patients aren’t aware of clinical trials. Dr. Omel explains,

“We definitely need to elevate the consciousness of the public about clinical trials; there’s no doubt about that. We need to educate the public about the providing of tissue, sharing clinical data. So many people have this misconception that they are “guinea pigs” which is a term we all abhor.” But it’s a term that people relate to clinical trials; they see themselves as test subjects rather than receiving the best of care, the most up to date care that you get with a clinical trial. A lot of it is public perception. We have to change this. As cancer research advocates, we are trying our best to get the word out.”

The internet and social media have done a good job in trying to get the word out about clinical trials. The government website, ClinicalTrials.gov lists all trials by illness and location and includes some brief help topics and a glossary of terms. And Cancer.gov  lists clinical trials specifically for types of cancers.

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Some patient support groups like PatientsLikeMe have their own clinical trial search tool. I took a look at the PatientsLikeMe tool and it did seem quite a bit more user friendly than the government site. It also mentions how many members of PatientsLikeMe may be eligible for the trial, links to a glossary and to the government site for more detailed information. I asked Paul Wicks, Vice President of Innovation at PatientsLikeMe about the tool and he explained,

“PatientsLikeMe’s global clinical trials tool draws on open data to match patients from around the world with a wide range of clinical trials based on their condition, location, age, or any other criteria. Patients can search for and identify a range of trials using a simple interface, and create a profile so they can be automatically alerted to trials that match their criteria.”

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When asked about the efforts of individual foundations and organizations in informing their members about clinical trials, Dr Omel explains,

“In the case of myeloma which I am most familiar with, the Multiple Myeloma Research Foundationand the International Myeloma Foundation have done a pretty good job of educating myeloma patients about new drugs and research going on. If you think about it, we have had six new drugs for treatment of myeloma in the last decade and that is unbelievable progress in oncology. The myeloma community really does work together and patients realize that we have these new drugs because patients before us signed up for those clinical trials.”

Another big issue with recruiting patients for clinical trials is the complexity of enrolling in the trial itself. The informed consent process is difficult to understand and many patients are daunted by the process.

Physicians can help explain the process, but again, often do not have the staff or the time. Families often cannot help unless they are familiar with the process. Patient Advocates certainly can and do help if they are available.

There are many issues to be covered during the enrollment process. What is the criteria for enrollment? How far does the patient have to travel? Will the patient have insurance coverage for standard care during a clinical trial? Will the patient get the new fancy drug or will they get a placebo or other type of treatment? Will the trial accept patients that have other health issues like a heart or kidney condition?

Informed consent should be written for the patient, but it is not. Providers and drug manufacturers want to be protected and often the complex medical and legal terminology included in the document is discouraging to a patient.

Efforts have been made to simplify the informed consent process. Fact sheets have been developed and videos have been made that try and explain the process easily so patients can understand.

PatientsLikeMe offers their clinical trial tool that helps simplify the process for their members, and other patient support sites may help walk their members through the process or have tools to help simplify things.

During my research on this subject, I came across an interesting product and website. Mytrus Enroll is a software product that simplifies  the informed consent process. The Mytrus website states:

“Enroll is a gateway technology that allows critical disclosure information to be condensed into an easy-to-understand, digitized format using animation, interaction, and visual imagery. Patients can interact with the app, marking terms and concepts that they want to discuss, completing easy to use knowledge assessments, and providing regulatorily ccompliant signatures to indicate their consent.”Image

I spoke with Michael Tucker at Mytrus and he explained that Mytrus is making great headway in the clinical trial tool arena. The company started by developing technology as a response to patients who wanted to participate in clinical trials but lived far away from a trial site. Mytrus wanted these patients to be able to enroll and participate in a trial mostly from their own home, reducing the amount of times they would have to go to the trial site for visits. With the technology they developed, patients can enroll remotely and go through the screening process using the Enroll software.

Mytrus tries to give patients a better understanding of the informed consent process and the clinical trial screening criteria by video (see here for a sample video). All Mytrus and Enroll videos and information are IRB approved.

Tucker went on to say that several studies have been done to determine the effectiveness of the video approach to the informed consent process. One such study done at the University of California at San Francisco showed that the comprehension and recall rate was superior in the video approach (75%) as opposed to the paper approach (58%).  Better comprehension is better for the patient and better for the study overall. Tucker further explains,

“The conclusion from this that is usually drawn is that if you have a higher comprehension rate, you will get better qualified patients. More patients will participate if they understand what is going on.”

While efforts are being made to better inform patients and the public in general about clinical studies, and the internet and technology seem to be helping the informed consent process, there is still a long ways to go as far as streamlining or adapting the clinical study process to make it more patient-friendly.

A big deterrent to adequate patient accrual for clinical trial is the way that the studies are designed. Often, the screening is very restrictive. Patients with any other conditions or illnesses besides the condition being tested are not permitted to take part in the study, greatly reducing the pool of potential participants.  Furthermore, often the patients are randomized in the study and many may never receive the new important drug being tested. Understandably, many patients react negatively to this and will refuse to participate in such a study. These obstacles will be difficult to overcome. Statisticians that build these studies want the restrictions and the randomization. Until there is a resolution to this problem, patient accrual will always be an issue. In an article he wrote for theMyeloma Beacon, Dr. Omel comments,

“What good is a statistically perfect, well-designed trial if nobody shows up?  Our current system is broken and needs new approaches to randomize patients based on their informed right to choose their own treatment.  This profound decision affects their life and their cancer.  Treatment should be their choice…

To all who denounce such an unscientific approach, please outline an improved system based on a patient’s absolute right to choose his treatment.  We can ‘think outside the box’ and use a different approach, or we can keep the same system and get the same results—3 percent participation with many drop-outs.  Without a change, we will continue to observe that only a tiny minority of clinical trials open, accrue, close, and are reported in a timely manner with useful information for clinicians and cancer patients.”

Resources:

http://www.pmlive.com/blogs/digital_intelligence/archive/2013/december/digital_recruitment_for_clinical_trial

http://www.mytrus.com/

http://www.ihealthbeat.org/insight/2012/social-media-offers-new-recruitment-strategy-for-clinical-trials

http://www.sireninteractive.com/sirensong/dr-katz-from-fda-talks-social-media-and-clinical-trials/

http://www.eyeonfda.com/eye_on_fda/2011/12/clinical-trials-and-social-media-part-1-in-an-intermittent-series.html

http://online.wsj.com/article/PR-CO-20130705-906183.html

http://www.patientslikeme.com/clinical_trials

 

This post was originally published on HealthWorks Collective

How Chronic Cancer Patients Use Social Media to Stay Informed

New research and treatment has made many cancers that were previously terminal now chronic. Patients live with the condition and daily go about their lives. But often, they do have to manage their cancer and often they worry about reoccurrence, side effects from medication and progression of the disease.

The chronic patient is often “forgotten”.  They are under treatment, doing (fairly) well, and doctors and the media are focusing on the more urgent issue of treating the acute or advanced cancer patient.

Chronic cancer patients want to know and understand their disease.  They would like a cure and they seek out the newest and latest information online looking for answers on treatment options, and how to best live with their disease.

Where can chronic cancer patients go for help online?

There are numerous sites for help with living with chronic cancer.  Many are disease-specific, offering news about new treatments or research.  There are several good video channels that offer interviews with cancer specialists about treatments, clinical trials or other information on specific cancers.  There are patient support networks and numerous Facebook pages that offer patients the opportunity to connect with other patients and post discussions about all aspects of their disease.

There is an overwhelming amount of information online and often, it is difficult to sift through all of it.

I have listed a few of these sites below.  In no way is this a comprehensive list, but I have asked several cancer patients and opinion leaders for their input and have added their thoughts to the list.

Resources for Chronic Cancer Patients

Cancer.gov

CLL Global

Patient Power

CanCare

Oncology Tube

National CML Society

Leukemia Lymphoma Society

Patients Against Lymphoma

CLL Topics

Institute for Myeloma and Bone Cancer Research

The Myeloma Crowd

International Myeloma Foundation

 

Facebook groups

Essential Thrombocythemia

Myeloproliferative Neoplasms

Polycythemia Vera & Budd-chiari Syndrome Awareness

 MPN Forum

Myeloproliferative Neoplasms 

 

Patient Opinion Leaders and Advocates

Another great way to obtain information on chronic cancers is to follow patient opinion leaders (POLs) on social media channels.  These patients have been living with their specific cancer (or cancers) for some time and have spoken about their experience (often publically), written books and articles about it, formed groups or even organizations or companies around chronic cancer.  They have Facebook pages, tweetchats, blogs, video programs and websites.  They organize patient meetings, interviews with physician specialists and events around their illness.  They have the experience and know-how to conduct excellent informational programs for other patients; they are a wonderful source of information.

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Andrew Schorr, @Andrew Schorr, founder of PatientPower and author of the Web Savvy Patient has been in remission from Chronic Lymphocytic Leukemia since 2001.  In 2012, he was diagnosed with a second cancer, myelofibrosis.  Andrew now leads a normal life, thanks to a new targeted oral therapy.  He has been a leader in patient education since 1984 and is considered to be one of the most respected and reputable Patient Opinion Leaders.

When I asked Andrew why he did what he did, he responded,

“I feel a responsibility to try to help other patients do better because of something I’ve learned through my experience. While others might wish to protect their privacy I “go public” with the hope to ease the journey of other cancer patients like myself. It helps me feel I am doing something significant and helps all of us know we are not alone, but rather a real community.”

Patient Advocates also help other patients by coaching them through living well and coping with their disease.  They use social media to spread the word about their illness and educate patients around the world.

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I also spoke with Cindy Chmielewski, @MyelomaTeacher, a former elementary school teacher and a multiple myeloma patient that is now a patient advocate for the disease.  Cindy is on the Board of Directors of the Philadelphia Multiple Myeloma Support where she is in charge of the Patient Education Library and Patient Advocacy. – She speaks at support groups, tweets about myeloma, and participates in several online support communities.

When asked why she did what she did, Cindy answered,

“Everyone needs a purpose in life.  Being a teacher for 28 years before my medical retirement I knew my purpose in life was to be a facilitator of information. When I regained my strength after my Stem Cell Transplant opportunities began to fall into my lap. I had some very good mentors when I was newly diagnosed. I am very grateful that I able to pay it forward. Sharing what I learn gives my cancer experience a purpose. Using social media allows me to reach a larger audience.  I am still a teacher, but now I teach a new subject with different students. We are all in this together and we can gain strength from one another. My life once again has meaning”. 

The Power of Social Media

Social media has drastically changed the idea of patient empowerment. Patients all over the world can connect, educate themselves and their family members, network, and instruct and educate others. And they are doing just that. The day of the passive patient is over: Welcome, empowered patient!

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Patient Power!

This post was originally published on HealthWorks Collective