Association of Funding and Conclusions in Randomized Drug Trials

作者：Bodil E Als-Nielsen, Wendong Chen, Christian Nyfeldt Gluud, Lise Lotte Kjaergard · 发表于：JAMA · 年份：2003 · DOI：10.1001/jama.290.7.921 · 被引用次数：746 · 研究领域：Pharmaceutical industry and healthcare、Meta-analysis and systematic reviews、Ethics in Clinical Research

CONTEXT: Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. OBJECTIVE: To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. DESIGN: Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). MAIN OUTCOME MEASURE: Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. RESULTS: The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logi...