Abstract
The Food and Drug Administration Amendments Act (FDAAA) created new requirements regarding registration of clinical trials and the posting of trial results in a public database, ClinicalTrials.gov. Some of the new requirements have already gone into effect while others must be established by rulemaking in the coming years. Specifically, FDAAA Title VIII requires that regulations must be issued by September 27, 2010, to expand ClinicalTrials.gov.
The Biotechnology Industry Organization's Clinical Committee and the Drug Information Association Clinical Trials Registry/Results Database Working Group conducted a questionnaire regarding ClinicalTrials.gov to better understand companies' and institutions' experiences with the registry, as well as policies and procedures regarding trial registration and results. In this article, we provide the comprehensive results of the questionnaire. Federal and state policymakers, as well as other organizations, may find sponsor results helpful as they develop new clinical trial registration and reporting policies.
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