2011/12/01 by Michael R. Law, Yuko Kawasumi, Steven G. Morgan · 1 citation
Medicine · Pharmacology, Toxicology and Pharmaceutics · Economics, Econometrics and Finance · Nursing · #Pharmaceutical studies and practices #Pharmaceutical industry and healthcare #Health Systems, Economic Evaluations, Quality of Life #Mandate #Clinical trial #Medicine #Government (linguistics) #Food and drug administration #Enforcement #Family medicine #Medical prescription #Off-label use #Public health #Prescription drug #Alternative medicine #MEDLINE #Environmental health #Political science #Pharmacology #Law #Nursing
paper · doi:10.1377/hlthaff.2011.0172
openalex publication_date 2011/12/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/31
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.