ClinicalTrials.gov

ClinicalTrials.gov is a federally supported, web-based clinical trials registry maintained by the United States (US) National Library of Medicine (NLM) at the National Institutes of Health (NIH). It is available to health care professionals, researchers, patients, and the public. Since its launch in 2000, over 325,000 clinical research studies have been registered in ClinicalTrials.gov. Unlike other clinical trial registries and databases, clinical trials registration for certain types of clinical trials is mandated by law under Section 801 of the US Food and Drug Administration Amendments Act (FDAAA 801). There are several components that make up the ClinicalTrials.gov registration process, including trial registration itself, results reporting, and the download and analysis of the ClinicalTrials.gov content. While the previous chapter focuses on clinical trials registration in general, this chapter pertains to clinical trials registered in ClinicalTrials.gov. This chapter provides an overview of the history of ClinicalTrials.gov, a description of the trials currently registered in ClinicalTrials.gov, and a review of the Federal Requirements for Registration in the United States. A summary of the registration process, trial reporting, and data analysis procedures follows. The chapter concludes with an overview of the limitations associated with the analysis and reporting of ClinicalTrials.gov registration data.