Older Adults Need Better Clinical Trial Representation; NIH Asks for Input

By Executive Director and CEO James Appleby, BSPharm, MPH

On June 1 and 2, I represented GSA at the National Institutes of Health workshop titled “Inclusion Across the Lifespan.” This workshop, mandated by the December 2016 passage of the 21st Century Cures Act, focused on identifying and addressing barriers to inclusion of broader age groups in clinical trials.

The program placed special emphasis on children and older adults. Representatives from the National Institute of Child Health and Human Development and National Institute on Aging, as well as NIH more broadly, were actively engaged.

There seemed to be broad agreement that age alone should never be an exclusion criteria for a clinical trial. The group acknowledged the extraordinary heterogeneity of the older adult population and the resulting challenges in designing clinical trials.

However, clear agreement on several other issues did not seem to emerge — including the development of functional assessments (versus age) for older adults in clinical trials, the inclusion of older adults with multiple comorbid conditions in research studies, and articulation of clearly defined age groupings for reporting results among older adults.

Workshop participants made numerous comments on the importance of making anonymized research data easily available to encourage meta-analysis across studies. There seemed to be general acknowledgement that this was happening now, but that it is a complex issue requiring additional work to fully unlock the value of already generated data.

Based upon input received at the workshop and additional online feedback, any needed inclusion policy updates are expected to be made by December 1. The NIH is welcoming input until June 30. I encourage you to submit your comments!