Slow Publication of Negative Trials
March 30, 1998
Slow Publication of Negative Trials
A diversity of health professionals, from clinician through basic scientist, depend upon published literature to direct their professional lives. Some concern has been expressed that studies with "negative results" may either be delayed in appearance, or fail to be published at all, distorting the balance of available information. Using a large database of HIV infection clinical trial protocols that include implementation milestones and publication dates, the author assessed all clinical efficacy trials from 1986 to 1996. Analysis was restricted to randomized comparative phase 2 and 3 trials, resulting in a sample of 109 trials and 43,708 patients.
Overall, positive trials were published significantly earlier than negative trials, with a median relative delay of 2.2 years. Multivariate analysis, including statistical significance of findings, sample size, accrual-to-target ratio, population age, design in reference to blinding, and data management (pharmaceutical vs other), delineated only significance of results as a determinant of time to publication.
The author notes that previous retrospective analyses have expressed concern of the effect of negative results on publication and suggests that publication lag "may affect evidence-based medicine and systematic reviews and may lead to spuriously larger treatment effects in early meta-analyses of the available evidence."
Ioannidis JP. JAMA 1998;279:281-286.
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