PMID: 9450711Feb 5, 1998Paper

Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials

JAMA : the Journal of the American Medical Association
J P Ioannidis

Abstract

Medical evidence may be biased over time if completion and publication of randomized efficacy trials are delayed when results are not statistically significant. To evaluate whether the time to completion and the time to publication of randomized phase 2 and phase 3 trials are affected by the statistical significance of results and to describe the natural history of such trials. Prospective cohort of randomized efficacy trials conducted by 2 trialist groups from 1986 to 1996. Multicenter trial groups in human immunodeficiency virus infection sponsored by the National Institutes of Health. A total of 109 efficacy trials (total enrollment, 43708 patients). Time from start of enrollment to completion of follow-up and time from completion of follow-up to peer-reviewed publication assessed with survival analysis. The median time from start of enrollment to publication was 5.5 years and was substantially longer for negative trials than for results favoring an experimental arm (6.5 vs 4.3 years, respectively; P<.001; hazard ratio for time to publication for positive vs negative trials, 3.7; 95% confidence interval [CI], 1.8-7.7). This difference was mostly attributable to differences in the time from completion to publication (median, ...Continue Reading

Citations

Sep 24, 1998·Lancet·J P Ioannidis, J Lau
Sep 10, 2013·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Deng-Xing LunBin-Wu Wang
Jun 3, 2014·BMC Medical Research Methodology·W Annefloor van EnstMariska M Leeflang
Nov 26, 2013·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Cuiling ZhouLianfeng Dou
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Jan 15, 2002·Proceedings. Biological Sciences·Michael D Jennions, Anders P Møller
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