title: Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.
abstract: Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.
authors.affiliation: Centre for Health Services and Policy Research at University of British Columbia, Vancouver, Canada. mlaw@chspr.ubc.ca
authors.forename: Michael R
authors.initials: MR
authors.lastname: Law
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kawasumi
authors.forename: Steven G
authors.initials: SG
authors.lastname: Morgan
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D016208:Databases, Factual / Q000706:statistics & numerical data*; D030881:Disclosure / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D004358:Drug Therapy; D019317:Evidence-Based Medicine; D033161:Government Regulation; D016018:Least-Squares Analysis; D037141:Mandatory Programs; D009316:National Institutes of Health (U.S.); D016016:Proportional Hazards Models; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration