Book Opens the Universe of Patient Engagement to Trial Volunteers and Professionals

Clinical Researcher—November 2019 (Volume 33, Issue 9)



With the insight of a thought leader and the perspective of a historian, Kenneth Getz has been a keen observer and important contributor to advancing clinical trials for many years. He’s just published the third edition of his popular book, “The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial.” Clinical Researcher Editor-in-Chief Michael Causey talked with Getz in late September on a wide range of topics, some of which were first presented in a recent ACRP blog.

In part one of the conversation, Getz discussed the ongoing evolution of patient engagement in clinical trials. In this segment, he describes how market demand compelled him to update the book, and how it helps fuel the overarching mission to deliver high quality clinical trials to patients everywhere.

You’re like James Brown, the busiest man in clinical trials show business out there. So, what compelled you to make the time to do this? Because writing a book takes time.

Kenneth A. Getz Speaking at ACRP 2019

Getz: I wrote the first edition in 2009 and it was written out of just growing demand. We were getting so many calls, so much interest from people who were thinking about clinical research—people who have been recently diagnosed and a clinical trial appeared to be a good option for them. And I just felt that if we could package a lot of good tips and pointers into a reference manual of some sort—one that’s just really written in plain language—that that would have some value and interest to people and to patients, and the book really took off. But since we first launched that early edition, the book has sold or has in circulation a total of about a quarter of a million copies.

For a very niche oriented publication, it just shows you the kind of demand and interest that’s out there, and we see this play out every time we have an educational event. Where we’ll see people who just come out of curiosity, not even for a health reason. They’ve just come to learn more because they see or hear an ad on the radio or they see a billboard on the highway or in the newspaper, and they want to just become more educated.

I think anybody not named Stephen King would be pleased to have anything close to those sales numbers. There’s obviously a need for and interest in this book.

Getz: And you know, that was an important part of the initiative, too. All of the proceeds from the book cycled back into CISCRP’s* other educational initiatives, so it’s another way to tie all this together. Interestingly, the very first edition of the book was recognized by the editors of the Merck manual. They then contacted me and asked me to write a chapter in the Merck manual on a clinical trial. So I adapted some of the material from “The Gift of Participation.” And a lot of this content also has taken on a life of its own and is appearing in a lot of other places. The Michael J. Fox Foundation has used some of the content from earlier versions of “The Gift of Participation,” and that’s really good to see as well.

How much has changed in the book in the last five years?

Getz: Between the first and the second edition there were changes, but in many cases I just added some supplemental paragraphs to existing chapters. This is the first edition where I really, completely revised the flow and rewrote whole sections and created a number of new chapters, most notably the one on patient engagement.

This new edition actually does talk about what the future might look like under patient-engaged clinical trials. The very first edition didn’t touch on any of this. I mean, it was 2009—it was sort of pre patient-centric clinical trials and patient-focused drug development, so before many of the initiatives that have come to help stimulate the development of more support for patient-engaged trial participation. The next edition, the second edition, touched on a few areas where we were really starting to see changes. The introduction of wearable devices and home nursing networks, for example, but it was still very, very early days.

This new edition puts all of this into its own chapter and talks about why this is such an incredibly exciting time for patients to be participating in clinical research. Because there’s so much focus on partnering with the patient, on improving convenience, on giving patients a voice in protocol design and helping to define clinically meaningful outcomes for the trials. Also in the return of trial results and the disclosure and transparency of what we learn in our studies, and in the role that broader data and analytics are playing and how we’re engaging stakeholders that have often been outside the research enterprise. And how they’re being engaged more actively, including by health systems and healthcare professionals, and even as payers in the whole clinical research enterprise.

The idea that you could participate in a clinical trial right at the point of care and throughout your own health journey [is a new concept]. So that’s more forward looking—the idea of the learning health system, where every time you take an over the counter medication or a prescription drug, whether it’s approved and commercially available or it’s an investigational therapy, something is learned about your response. And that ultimately is aggregated to inform our understanding about population health and how people are responding to different therapies and treatments over their own health journey over the course of their own lifetime. “The Gift of Participation” frames so much that has happened over the last five or six years and talks a bit about the promise that it holds for the future.

It’s interesting you bring that up as a topic as one of the things I want to focus on, partially riffing off the title of the book itself, but I think sometimes in this industry we don’t always appreciate the patients. We don’t really appreciate the efforts they make or we can overlook their role. So talk about what does the title “The Gift of Participation” mean to you? Why did you select that as a title?

Getz: It’s such a great question because it really goes back to the creation of CISCRP itself, which occurred in 2003, and looking for a language or phrases that would convey our appreciation and our admiration for people who decide to participate in clinical research—most often to benefit others. Because the vast majority of trials provide no benefit directly to the volunteer. And so “The Gift of Participation” was, in very simple language, a phrase that we used to really try to reorient our thinking about the heroes—the people who make the choice to help improve our overall knowledge of disease and how to treat it. The people who make decisions to act in ways that may bring no personal benefit to themselves, but bring benefit to others. And that’s truly a gift that they give.

*Proceeds from “The Gift of Participation” fund educational programs of the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP), for which Getz is founder and chair in addition to being deputy director and research professor at the Tufts Center for the Study of Drug Development. To find out more, go to