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

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=2.6x10^-9). Later phase trials were more likely to report results
(P=4.4x 10^-11), as were industry funded trials (P=2.2 x10^-16).
CONCLUSION: Most trials subject to mandatory reporting did not report
results within a year of completion.