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October 16, 2018

Inclusion Across the Lifespan: NIH Policy for Clinical Research

Author Affiliations
  • 1National Institute on Aging, National Institutes of Health, Bethesda, Maryland
  • 2Office of Research in Women’s Health, National Institutes of Health, Bethesda, Maryland
  • 3Office of Extramural Research, National Institutes of Health, Bethesda, Maryland
JAMA. 2018;320(15):1535-1536. doi:10.1001/jama.2018.12368

In 2005, a trial supported by the National Institutes of Health (NIH) that included patients with a mean age of 60 years demonstrated that implantable cardioverter-defibrillators had improved survival rates over amiodarone in patients with congestive heart failure.1 This study and another that examined cardioverter-defibrillator therapy contributed to change in clinical practice.2 However, 40% of patients who subsequently received cardioverter-defibrillators were older than 70 years and 10% to 20% were older than 80 years,2 illustrating the importance of adequate inclusion of appropriate populations in clinical studies. In a review of 109 clinical trials, Zulman et al found inadequate inclusion of older adults to allow for informed decision making.3 In a review of 338 phase 3 and phase 4 NIH-funded studies that were actively recruiting in ClinicalTrials.gov, Spong and Bianchi noted that 75.7% explicitly excluded children, contributing to problems with adequate information for pediatric dosing and other interventions.4