EXCLUSION OF OLDER PATIENTS IN CLINICAL DRUG TRIALS

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DESCRIPTION (provided by applicant): Individuals 65 years of age and older represent the highest per capita consumers of healthcare in the United States, with greater than $530 billion spent on medical care and $56 billion on prescription drugs annually. However, clinicians caring for these patients frequently lack relevant medical evidence to guide their clinical decision-making and ensure that the optimal care is provided. There is concern that randomized controlled trials (RCTs)-considered the highest level of evidence supporting medical decisions-persistently exclude and underrepresent older individuals in trials across a spectrum of disease conditions. As a result, clinicians must extrapolate results derived from trials on younger patients despite known age-related differences in pathophysiology and response to treatment. Though the lack of high quality evidence to support medical management in older patients has been previously recognized, there has not until now been an adequate data source for comprehensive surveillance of the research portfolio pertaining to elderly subjects. This proposal uses a unique resource-ClinicalTrials.gov-and develops methods to, for the first time, take stock of the entire research portfolio, assessing the relevance and alignment of research with actual disease burden among older individuals as well as quantifying and characterizing the exclusion of this population from research activity. We propose to use the registry to analyze randomized controlled drug trials in three specific aims: 1) To measure the relevance of current research that does include elderly persons in relation to the disease burden in these patients; 2) To quantify the extent to which elderly persons are excluded in the clinical research enterprise as a whole; and 3) To identify the characteristics of RCTs that exclude elderly patients. We hypothesize that the focus of RCTs that include older patients corresponds poorly to high priority areas defined by actual global disease burden among the elderly. Further, we hypothesize that a substantial proportion of drug trials exclude older patients not only based on age but also indirectly through other types of exclusion factors. Because the body of clinical trials is constantly evolving, this work provides not only a snapshot of current drug trials, but also a framework and toolkit for surveillance of the evidence base going forward. Metrics developed under these aims will be made publicly available through a prototype of a web- based front application to ClinicalTrials.gov that automatically displays the current status of clinical trials pertaining to older patients.