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A New Mechanism for Tracking Publicly Available Study Volunteer Demographics

Title
A New Mechanism for Tracking Publicly Available Study Volunteer Demographics

Abstract
The importance of gathering and monitoring aggregate demographic data on the annual population of study volunteers in FDA-regulated clinical trials is widely acknowledged. To date, no formal mechanism exists to capture this information. The Tufts Center for the Study of Drug Development identified and tested a publicly available source of information on clinical trial participant data, NDA Reviews stored in the FDA’s drugs@FDA database, to determine its accuracy, reliability, and feasibility. Thirty-seven new drug applications approved between 2006 and 2008 were evaluated and compared with published sources of demographic data. The authors conclude that the approach described here— NDA review extraction—provides reasonably reliable and conservative estimates of study volunteer demographics and can serve as a useful baseline until Clinicaltrials.gov or other, more complete, public sources become available.