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Re: Adequacy of Inclusion of Older Adults in NIH-Funded Phase III Clinical Trials.

available at http://www.ncbi.nlm.nih.gov/pubmed/30693958 Editorial Comment: A major criticism of many clinical trials is that geriatric subjects, particularly those with multiple comorbidities or any degree of frailty, are often excluded. This is due to stringent enrollment criteria for most studies that preclude participation by many elderly subjects. The problem is that assessment of these therapies in younger and healthier people yields data that cannot always be accurately extrapolated to the actual target population. This study conducted by leaders from the National Institutes of Health evaluated whether their own funded, phase III, research trials for the most common disorders associated with hospitalization or disability in geriatrics adequately included older adults. The authors assessed numerous studies examining various cardiopulmonary conditions, 15 osteoarthritis trials and 65 prostate cancer trials. Overall, they found that 33% of trials set an arbitrary upper age limit and 67% reported data that skewed younger than the mean and/or median age for the conditions of interest. Aside from age itself, most studies excluded older adults due to comorbidities including cardiac conditions (30%), polypharmacy or specific medications (37%) and other functional status parameters. Of the 65 prostate cancer trials 25 (38.5%) set an arbitrary upper age limit and 4 (16%) excluded all people 75 years old or older. Interestingly of the numerous conditions examined prostate cancer was the only one that had no trials excluding people 65 years old or older. The results indicate a strong need for future work that actively enrolls older adults to help with generalizability of findings to the actual target populations. Tomas L. Griebling, MD, MPH 860 GERIATRICS Copyright © 2020 American Urological Association Education and Research, Inc. Unauthorized reproduction of this article is prohibited.