Publication of trials funded by the National Heart, Lung, and Blood Institute.
BACKGROUND
Rapid publication of clinical trials is essential in order for the findings to yield maximal benefits for public health and scientific progress. Factors affecting the speed of publication of the main results of government-funded trials have not been well characterized.


METHODS
We analyzed 244 extramural randomized clinical trials of cardiovascular interventions that were supported by the National Heart, Lung, and Blood Institute (NHLBI). We selected trials for which data collection had been completed between January 1, 2000, and December 31, 2011. Our primary outcome measure was the time between completion of the trial and publication of the main results in a peer-reviewed journal.


RESULTS
As of March 31, 2012, the main results of 156 trials (64%) had been published (Kaplan-Meier median time to publication, 25 months, with 57% published within 30 months). Trials that focused on clinical events were published more rapidly than those that focused on surrogate measures (median, 9 months vs. 31 months; P<0.001). The only independent predictors of more rapid publication were a focus on clinical events rather than surrogate end points (adjusted publication rate ratio, 2.11; 95% confidence interval, 1.26 to 3.53; P=0.004) and higher costs of conducting the trial, up to a threshold of approximately $5 million (P<0.001). The 37 trials that focused on clinical events and cost at least $5 million accounted for 67% of the funds spent on clinical trials but received 82% of the citations. After adjustment of the analysis for a focus on clinical events and for cost, trial results that were classified as positive were published more quickly than those classified as negative.


CONCLUSIONS
Results of less than two thirds of NHLBI-funded randomized clinical trials of cardiovascular interventions were published within 30 months after completion of the trial. Trials that focused on clinical events were published more quickly than those that focused on surrogate end points. (Funded by the National Heart, Lung, and Blood Institute.).
From the Office of Special Projects of the Division of Cardiovascular Sciences (D.G., W.T.-P., A.M.), Office of Science and Technology (M.A.), the Clinical Applications and Prevention Branch of the Division of Cardiovascular Sciences (P.G.K.), and Office of the Director of the Division of Cardiovascular Sciences (M.S.L.) - all at the National Heart, Lung, and Blood Institute, Bethesda, MD.
David
D
Gordon
Wendy
W
Taddei-Peters
Alice
A
Mascette
Melissa
M
Antman
Peter G
PG
Kaufmann
Michael S
MS
Lauer
D002318:Cardiovascular Diseases / Q000628:therapy; D005380:Financing, Government; D006801:Humans; D053208:Kaplan-Meier Estimate; D054555:National Heart, Lung, and Blood Institute (U.S.); D010506:Periodicals as Topic / Q000706:statistics & numerical data*; D011643:Publishing / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000706:statistics & numerical data*; D012109:Research Support as Topic; D013997:Time Factors; D014481:United States