Second Edition of The Gift of Participation Available: A Q&A with the Author

If you are interested in Patient Centered Clinical Trials, or Patient Centricity, then you will be aware of the barriers patients have to participating in clinical trials. Once the initial barriers of lack of knowledge are overcome, the remaining challenges are industry-inherent. Those include, and are not limited to: education about what a clinical trial entails; difficulty in understanding the lengthy informed consent forms; difficulty in traveling to an investigative site; invasive or time-consuming procedures required; lack of follow-up about the trial once they leave. The patient-centric “movement” is all about putting the patient in mind—even including patients and patient groups, online or in-person—in the protocol development process.

As even most recent history has shown, the lack of attention paid to the actual patients in clinical trials, the subjects—now more appropriately called participants, —has led to the industry’s most pivotal challenge, study recruitment and retention. Patient centricity not only seeks to improve that model, but in some cases to flip it on its head.

But before the online movement in health became so strong, and clinical trials’ necessity to reduce inefficiencies, a handful of people identified the patients as the ones who needed the most help in navigating clinical trials. And Kenneth Getz, founder and Chairman of the Center for Information and Study of Clinical Research Participation or CISCRP; founder of CenterWatch; and Director of Sponsored Research at Tufts CSDD, wrote a book for patients, families and caregivers called “The Gift of Participation: A Guide to Making Information Decisions About Volunteering for a Clinical Trial.”

Now with the second edition of the book available, Getz spoke to Applied Clinical Trials about the book, as well as the changes in clinical trials since the first edition.

When you first wrote the book, how many resources would you say were available to the public about clinical trials, and in what formats or venues?
There were far fewer resources available in 2006/2007. Many of these resources were only available in paper format and it was difficult to find them.  Wider reaching, more accessible, and more sophisticated web-based approaches—including social and digital media—have really proliferated.  During the past several years there has been growing receptivity to providing links to other sources for information and this too has helped enrich the breadth and depth of educational resources available.

When you wrote the book, your company CenterWatch included and still includes other patient-directed services. How have the services changed over the years?
CenterWatch has always tried to be a neutral publisher and reference resource for patients.  To my knowledge, it was the first company to develop balanced, objective pamphlets explaining the clinical research process to patients and study volunteers.  In 1995, CenterWatch launched the Clinical Trials Listing Service for patients and their families to find industry-funded clinical trials.  CenterWatch added a number of online resources associated with the trial listing service including information about newly approved drugs and experimental treatments in clinical trials for patients and their health care provider to use.  Today, CenterWatch educational pamphlets are still ordered and distributed by clinical research and healthcare providers.  And its online Clinical Trial Listing Service is the largest source for information on active FDA-regulated, industry-sponsored clinical trials online, attracting more than 130,000 unique patient visits monthly. Several years ago, CenterWatch began directing its patient visitors to CISCRP’s web site for those looking for more in-depth educational information.

When you hear the term patient-centricity in regard to clinical trials, what do you think of?
I’ve been writing and speaking extensively about this in Applied Clinical Trials and elsewhere.  Patient-Centricity is all about engaging patients as partners in clinical research.  That partnership is manifest in all areas of the drug development continuum including more feasible protocol designs; more active participation and feedback from patients throughout study conduct; more convenient and easier trial participation; and in delivering clinical trial results in lay language summaries to volunteers who gave us the gift of their participation. The ultimate test for a successful patient centricity movement will be in seeing measurable improvement in the public’s support in and commitment to the success of clinical trials.

Why do you think industry still struggles with patient recruitment?
There are many factors involved.  Hyper complex protocol designs and industry’s failure to engage patients, the public, and healthcare provider communities are some of the largest contributing factors.  The ways that industry works with and supports investigative sites also harms patient recruitment and effectiveness.  A patient-centric philosophy and approach should help address many of these long-standing challenges.

What do you think of websites such as Patients Like Me and Smart Patients?
Any web sites and social media communities that help inform, empower, and engage patients and their families are important to the long-term success and viability of the clinical research enterprise.  I’m personally interested in seeing how many of these innovative and progressive approaches can be integrated to collectively support the clinical research enterprise.  Often many of these new initiatives detract from the hard word and impact of individuals and offerings that have come before them. 

In updating the second edition, what information did you include that you might have thought would never be needed in a patient guide?
Nothing has really surprised me.  In addition to describing the study volunteer process, the first edition laid the foundation for a very balanced and objective educational resource shedding light on the benefits and risks of clinical research as well as the laudable and shameful moments in the history of the clinical research enterprise.  This latest edition updates all of the data and information and adds more about personalized and stratified medicine and why clinical trials are collecting more genetic material and biomarker data.  The new edition also looks at the Sunshine Act. One area that I found personally interesting:  I focused much more attention on the obligation of patients and study volunteers to be aware of the importance of maintaining research integrity.  As partners in the process, especially given the advent of social media in clinical research, study volunteers have an obligation to not divulge information about their study drug or to try to break their randomization cohort.

How difficult is it to translate medical and scientific language into language that most people can understand and be comfortable of its credibility?
Translation is not nearly as difficult as many believe. We often forget that patients dealing with a life threatening or debilitating illness are uniquely motivated to learn as much as they can about their medical condition and their health. Investigative site personal often comment on how knowledgeable are their study volunteers. As partners in clinical research, patients must be treated respectfully with recognition that they want to receive technical information that would typically be too difficult for the lay public to comprehend.  Credibility is more difficult because the potential for conflicts of interest to bias information abounds.  As a neutral and independent nonprofit organization that specializes in patient education and outreach, CISCRP is uniquely positioned to develop and disseminate credible, unbiased lay-language summaries of clinical trial results.  And CISCRP leverages an independent lay community editorial board to ensure that the language is objective, at an appropriate reading level for patients and their families.