Association for Public Policy Analysis & Management

Clinical trials are conducted in order to test the efficacy and safety of various interventions (e.g. drugs, surgery, biological, or devices) on human volunteers to answer specific health questions before those interventions are used in the general public. Federal laws have mandated that all clinical trials must include women, children, and minorities, when appropriate. Currently, similar guidance does not exist to include older adults. In fact, a growing body of evidence is demonstrating that older adults are not adequately included in clinical trials. This is particularly problematic if a specific intervention is going to be used to treat elderly patients. This analysis examines the representation of elderly populations (65 years or older) in NIH-funded Phase III clinical trials and the trials’ inclusion/exclusion criteria that may limit the participation of older people in clinical trials. We focused on diseases that are top causes of hospitalization or disability adjusted life years in the older population (e.g. heart disease, pneumonia, osteoarthritis) and collected a random sampling of completed clinical trials from www.clinicaltrials.gov (CT.gov). We then examined the QVR database, CT.gov and associated publications for data on the ages reported in the progress reports, age ranges reported in publications, and specific exclusion criteria for each study. This analysis found that while the diseases examined have a high prevalence in older populations, the clinical trials focusing on these diseases may potentially exclude older adults. When examining the exclusion criteria for these studies, almost all list among them diseases that are likely to be found in older populations (e.g. hypertension, diabetes, renal disease). Further, several studies excluded people on specific medications or on multiple medications. Taken together, we have found that NIH-funded Phase III clinical trials may be excluding older adults from studies where the disease has a higher prevalence in this population.