Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research conducted after regulatory approval for marketing. For certain drugs, the US Food and Drug Administration (FDA) is authorized to require postmarket studies, including submission of status reports and final results. Sponsors of certain applicable clinical trials1 are also required to publish summary results at the ClinicalTrials.gov website (https://clinicaltrials.gov/). Amid increasing calls for transparency in research,2 we describe publication rates and characteristics of postmarket drug studies.
Cruz ML, Xu J, Kashoki M, Lurie P. Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013. JAMA Intern Med. Published online May 15, 2017. doi:10.1001/jamainternmed.2017.1313