As the U.S. Food and Drug Administration gets serious about requiring diversity plans for clinical trials, and as the use of decentralized clinical trial (DCT) designs increases the appeal of study participation for patients, expert contributors to the forthcoming February 2023 issue of ACRP’s Clinical Researcher journal caution that careful planning for patient retention efforts are still necessary to reap the benefits of these trends.
A key focus in the clinical trial diversity plans that are part of this year’s omnibus spending bill signed by President Biden should be participant payments and reimbursement, writes Kelly FitzGerald, PhD, IRB Executive Chair and Vice President for IBC Affairs at WCG IRB.
“Appropriate payment to research participants is a critical aspect of diversifying clinical research participation,” FitzGerald notes. “Research studies often involve frequent appointments, and without appropriate compensation, many potential participants will be left out. …[However, institutional review boards (IRBs)] are often seen as a barrier to paying participants in clinical research. While that may have been true in the past, thinking on this topic has evolved significantly during the past few years, informed in part by recognition of the importance of research participants as partners rather than as research ‘subjects.’”
FitzGerald explains that IRBs are tasked with ensuring that research recruiting and consenting processes do not exert undue influence on participants, and high payments may be seen by IRB members as unduly influential. “Their concern is that payments could incentivize someone to participate in activities they would otherwise choose not to pursue—particularly people with low incomes,” she writes. “However, when an IRB insists on lower payments, participants who have less free time, less available income, or more burdensome lives are less likely to participate, and the study ends up with a participant population that does not match society because only those people who can bear the financial burdens of research participation will enroll.”
Thankfully, the clinical research enterprise now recognizes that payments can incentivize participants without being unduly influential. “While there is a perception that IRBs will not approve high payments for participants, that is changing,” FitzGerald notes. “The time has come for sponsors and clinical research organizations to accurately assess the costs to individuals tied to their research participation and provide them with just compensation for their service. Appropriate compensation should be considered in the context of the overall goal of improving diversity in clinical trials.”
Meanwhile, as DCTs become more prevalent, particularly in the wake of the pandemic, their lower burden approach can make participation more attractive for some. Yet the vexing issue of retaining participants throughout the course of a trial will continue to be problematic without a thoughtful approach to keep them engaged, writes Ingrid Oakley-Girvan, PhD, MPH, Senior Vice President of Value and Strategy at Medable Inc., who goes on to provide the details of a three-phase model of engagement, based on proven science and intelligently informed by utilizing data, that she notes can make important inroads into solving this long-standing challenge.
“While concerns about how to successfully increase access and the pace of enrollment for clinical trials have often kept principal investigators and sponsors up at night, retaining enrolled participants is also critically important to consider,” Oakley-Girvan explains. “Poor retention rates can lead to increased costs and a loss of useful data for regulatory submission. Retention throughout each phase of a clinical trial plays an important role in a study’s success, both from an economic and scientific point of view.”
A growing discontent among prospective participants over the disruptive nature of traditional clinical trials presents a clear opportunity to do things differently, Oakley-Girvan writes. Prospective clinical trial participants “have a clear preference for studies that are more convenient and less demanding on their time,” she adds. “Decentralized trials (which invariably require less travel, less time spent in clinical settings, and incorporate more convenient methods of communication) clearly fit the bill.”
Would a shift to participant-preferred DCTs automatically reduce the challenges of retention? Oakley-Girvan cautions that there are countless reasons why noncompliance and poor retention occur in healthcare settings. “Even when a participant has every intention of completing a study, there are a myriad of reasons why they might lose their motivation and drop out,” she writes. “Yet, this outcome can be greatly improved through thoughtful and intentional engagement. …There are no simple solutions. However, a lot can be learned from the extensive body of work across the behavioral, cognitive, and psychosocial sciences. Moreover, understanding how the most successful digital platforms engage their users can also provide some valuable insight.”
Edited by Gary Cramer