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# Too Few Older Adults in Trials: Study
- URL: https://www.fdaweb.com/too-few-older-adults-in-trials-study/
- Published: 2022-10-18T12:00:00.000Z
- Updated: 2026-09-14T18:03:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152994

FDA and academic researchers say the results of a cross-sectional study suggest that a lack of adequate representation of older adults in clinical trials for new drug evaluation can present challenges for optimal use and prescribing. The study results were [published](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797323?ref=fdaweb.com) in the open-access *JAMA Network Open*.

The researchers analyzed FDA data for NDAs and BLAs approved from 2010 through 2019\. They say that the age distribution of clinical trial participants was compared with age distribution of the U.S. population with the disease or disorder. Data were from adults enrolled in registration trials for depression, heart failure, insomnia, non-small cell lung cancer, nonvalvular atrial fibrillation stroke prevention, osteoporosis, and Type 2 diabetes, or adults sampled from U.S. prevalent population in community-dwelling health data.

“While representation of older age subgroups varied by treatment indication,” the authors say, “the most consistent finding was the limited enrollment of the oldest age groups. Specifically, those ages 75 years and above for Type 2 diabetes and non-small cell lung cancer, and 80 years and above for nonvalvular atrial fibrillation stroke prevention, insomnia, heart failure, and osteoporosis. The inclusion of older patients from 60 to 75 years of age in clinical trials was reasonably close to the corresponding prevalence of the treatment indication in older adults.”

The researchers conclude that “data on safety and efficacy of medications across the entire older age span are important to appropriately care for this growing older population. Although there are long-standing FDA guidances that the clinical trial participant pool should represent the population that will ultimately receive the product, there continues to be room for improvement. A clinical trial ecosystem needs to be developed to acquire and provide this information so that it can be used to optimize prescribing at the time of introduction of drugs into clinical care.”