With the perspective of a historian, long-time clinical trial thought leader Kenneth Getz has seen buzzwords and trends come and go. 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 clinical trial topics. In this excerpt from the full interview, Getz discusses how the concept of patient engagement has changed dramatically since he published the first edition of the book in 2009.
Do you have any prognostications about how patient engagement might evolve over the next several years?
Getz: 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.
How has the concept of patient engagement changed between the first edition and now?
Getz: 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.
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 https://ciscrp-educational-resource-store.myshopify.com/products/the-gift-of-participation-a-guide-to-making-informed-decisions-about-volunteering-for-a-clinical-trial.
Editor’s Note: A longer version of this interview will appear in the November issue of Clinical Researcher from ACRP.