Inclusion of Older Adults in NIH-funded Phase III Clinical Trials

Drs. Jaron Lockett and Samir Sauma (from NIA’s Office of Planning, Analysis, & Evaluation), Dr. Barbara Radziszewska (from NIA’s Division of Geriatrics and Clinical Gerontology) and Dr. Marie A. Bernard (NIA’s Deputy Director), authored a recent article on 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.  Despite these findings, the authors are hopeful that new guidelines on the inclusion of individuals across the lifespan may lead to a greater representation of this population in future studies.  The new policy, which went into effect recently, 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.  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 American Medical Association in October 2018; this article was co-authored by Dr. Bernard 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).

Check Out This NIA Informational Video Narrated by Dr. Richard Hodes, NIA’s Director

The NIA released an informational video about the Institute’s mission, history, and research that has led to important scientific discoveries about healthy aging. The video can be found on the NIA’s YouTube channel and via the NIA website . Narrated by Dr. Richard Hodes, NIA’s Director, the piece combines photos, animation, video clips, illustrations, and other dynamic elements to convey the history and work of the Institute. Please feel free to share the link to this video with anyone that you think would be interested in learning more about the nation’s lead agency on aging research!

NIA Announces Increased Pay Lines

In this week’s NIA Blog, Dr. Robin Barr, Director, Division of Extramural Activities, writes about the impact of the 5% increase in general appropriations to the NIA.  Read more here.   You can see all of these numbers in a table. The Alzheimer’s and related dementias funding lines have not changed from the May posting.

NIA Launches iCare-AD/ADRD Challenge

The NIA launched the Improving Care for People with Alzheimer’s Disease and Related Dementias Using Technology (iCare-AD/ADRD) Challenge.  This Eureka prize competition seeks to spur the development of technology applications to improve dementia care coordination and/or care navigation, as part of the implementation of the 21st Century Cures Act.  Up to $400,000 in cash prizes may be awarded to teams or individuals that participate in the challenge.  Entries will be accepted from October 1, 2018 through June 30, 2019.

The iCare-AD/ADRD challenge managers will be hosting a webinar on October 17, 2018 at 2:30 PM EDT.  This webinar will introduce attendees to the Challenge and cover participation requirements.  Time will be allotted to answer questions from attendees.  To register for the webinar please visit: https://bit.ly/2MhGc7w.

Please share this announcement broadly; NIA is interested in receiving applications from all relevant sectors.  The NIA is excited to see what types of innovations will be sparked from this competition!