Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

• Published in: BMJ 2012-01, Vol.344 (7838), p.15-15
• Main Authors: Prayle, Andrew P, Hurley, Matthew N, Smyth, Alan R
• Format: Article
• Language: English
• Subjects: Bias; Clinical trials; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - statistics & numerical data; Compliance; Cross-Sectional Studies; Databases, Factual - statistics & numerical data; Disclosure - legislation & jurisprudence; Disclosure - statistics & numerical data; Drug development; Experimentation; FDA approval; Federal legislation; Government Regulation; Information sharing; Legislation; Mandatory Programs; Modernization; Registration; Registries; Reporting requirements; Requirements; Studies; United States; United States Food and Drug Administration
• ISSN: 0959-8138; 0959-8146; 1468-5833; 1756-1833
• DOI: 10.1136/bmj.d7373

Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year.Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.Main outcome measure Proportion of trials for which results had been reported.Results The ClinicalTrials.gov registry contained 83 579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ2 test, P=2.6×10−9). Later phase trials were more likely to report results (P=4.4×10−11), as were industry funded trials (P=2.2×10−16).Conclusion Most trials subject to mandatory reporting did not report results within a year of completion.