Clinical Trials and Older Adults

Recruiting Older Adults for Clinical Trials: Communication Tips for Clinical Investigators

• Vignette

Until recently, older adults were generally not well-represented in clinical trials. As a result, the evidence base for guiding treatment in this population is less robust than for younger adults. Efforts are underway to ensure that more diverse patient populations are included in clinical trials. Therefore, enrolling older adults in clinical trials is important for supporting these efforts. Increasing communication with older adults about clinical trials is likely to improve enrollment. In fact, more than two-thirds of Americans say it’s likely they would participate in a clinical trial if recommended by their doctor. In this video, we will review tips for communicating with older adults, including both general communication strategies and specific points for discussing clinical trial enrollment.

Clinical Trials and Older Adults — Strategies to Drive Older Adult Participation

Momentum Discussion at GSA's 2018 Annual Scientific Meeting
Moderator: Stephanie A. Studenski
Panelists: Roger A. Fielding, Jay S. Magaziner

Individuals enrolled in a clinical trial of a novel intervention ought to represent those who are intended to benefit. However, older adults, especially those with multimorbidity or frailty, are under-represented in most trials, even when they may benefit and are likely to use the intervention in real life. While practical barriers and unnecessary research assumptions have limited participation, multiple feasible solutions exist. This session, based on a recent conference, described the strengths and limitations of trial design and implementation strategies that can open the door to greater participation by, and generalizability to, a broad range of older adults.

• Slides
• References

Resources

• NIH-Funded Clinical Studies - Guidelines on the inclusion of individuals across the lifespan. These new guidelines may lead to a greater representation of this population in future studies. The new policy mandates that all applications for NIH-funded clinical studies received after January 25, 2019 include research participants across the lifespan, including children and older adults (unless there is a scientific justification to exclude them). The new policy also requires investigators to provide data on participant age at enrollment in progress reports. The NIH is optimistic that these changes will enhance recruitment across all ages and yield trial results that are more generalizable to the population.
• Inclusion Across The Lifespan-II Workshop Report. The NIH has taken steps to promote broad inclusion in clinical trials. Although there have been improvements in many areas, it is vital to regularly assess how implementation is proceeding to identify obstacles and any further actions needed to carry out the full intent of the Inclusion Across the Lifespan policy. To this end, a workshop — Inclusion Across the Lifespan Workshop (IAL-II) — was planned and held on September 2, 2020.

Pertinent Articles

• “The Inclusion of Older Adults in NIH-funded Phase III Clinical Trials.” This article, published in the Journal of the American Geriatrics Society, describes an analysis conducted by the NIA on the number of older adults included as participants in NIH-funded phase III clinical trials between 1965 and 2015. The data reflect a disproportionate underrepresentation of older adults in these clinical studies, through both explicit and implicit exclusion criteria and suggest that outcomes of the trials may not be fully generalizable to the population of older adults.
• The ongoing efforts to revisit and revise the NIH-wide inclusion policy, as mandated in the 21st Century Cures Act passed in 2016, were discussed in a Viewpoint Essay published in the Journal of the America Medical Association, October 2018; this article was co-authored by Dr. Marie Bernard (Deputy Director of the National Institute on Aging) with Dr. Janine Clayton (Director of the NIH’s Office of Research on Women’s Health), and Dr. Michael Lauer (NIH’s Deputy Director for Extramural Research).