Publication of Trials Funded by the National Heart, Lung, and Blood Institute

Abstract

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.)

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

“…8 Similarly, an analysis of 244 extramural clinical trials supported by the National Heart, Lung, and Blood Institute and completed between 1 January 2000 and 31 December 2011 found that 43% of clinical trials remained unpublished within 30 months. 16 Our analysis extends previous work by reporting publication rates across leading academic institutions and shows a nearly twofold variation in the rate of publication overall and a more than threefold variation in the rate of publication within 24 months. With regard to reporting of results on ClinicalTrials.…”

Publication and Reporting of Test Accuracy Studies Registered in ClinicalTrials.gov

“…These numbers may be considered as optimistic, because we excluded studies that had enrolled patients but discontinued before study completion. Two recent evaluations with study designs similar to ours assessed time to publication among registered clinical trials funded by the NIH (17 ) and the National Heart, Lung, and Blood Institute (18 ). Respectively 46% (294/635) and 57% (132/244) of the trials had been published within 30 months of completion, which is comparable to the 45% rate found in our study.…”

Multi-state analysis illustrates treatment success after stem cell transplantation for acute myeloid leukemia followed by donor lymphocyte infusion

“…These issues can only be addressed properly in prospective randomized trials. 30,31 However, in current transplant practice, randomized trials are performed infrequently due to both the relatively small numbers of patients affected and to patient and physician treatment preferences. 32 This lack of randomized trials necessitates alternative analysis methods, in which as many insights as possible are extracted from observational data.…”