Clinical Trials

In September 2008, the National Library of Medicine (NLM) of the National Institutes of Health (NIH) expanded the database at ClinicalTrials.gov to include the results of registered clinical trials in response to the Food and Drug Administration Amendments Act (FDAAA). This database consists of structured tables of summary data regarding the results of trials without discussion or conclusions. The FDAAA, its implementing regulations (42 CFR Part 11),2,3 and several policies require the reporting of results to ClinicalTrials.gov to address issues related to the nonpublication of results of clinical trials and incomplete reporting of outcomes and adverse events. These issues have necessitated process changes for sponsors and investigators in both industry and academic medical centers. We previously estimated that the regulations and the trial-reporting policy of the NIH would affect more than half the registered trials conducted at academic medical centers in the United States. The scope and importance of these requirements demand that we monitor and evaluate the effect of this evolving results-reporting mechanism on the clinical trials enterprise. In 2011, we characterized early experiences with nearly 2200 posted results. A decade after launch, the results database contained more than 36,000 results as of May 2019. In this article, we de- scribe the current requirements, the state of results reporting at ClinicalTrials.gov, and challenges and opportunities for further advancement.