Centre for Evidence-Based Medicine Odense (CEBMO), Odense University Hospital, Kløvervænget 10, 13th Floor, Gate 112, 5000, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Intensive Care Med. 2018 Oct;44(10):1603-1612. doi: 10.1007/s00134-018-5293-7. Epub 2018 Aug 21.
Clinical research is widely sponsored by drug and device companies. We investigated whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. This review is an update of a previous Cochrane review.
In this update we searched MEDLINE and Embase (2010 to February 2015), Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). We included empirical studies that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. Two assessors included papers, extracted data and assessed risk of bias. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether conclusions agreed with results.
We included 27 additional papers in this update (review now includes 75 papers). Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI 1.17-1.37), no difference in harms results RR: 1.37 (95% CI 0.64-2.93) and more often favorable conclusions RR: 1.34 (95% CI 1.19-1.51) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in reporting of data and heterogeneity of results. Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI 1.05-1.50), compared with non-industry sponsored studies.
Drug and device studies sponsored by manufacturing companies have more favorable efficacy results and conclusions than studies sponsored by other sources.
临床研究广泛受到制药和医疗器械公司的赞助。我们调查了与其他来源赞助的研究相比,制药和医疗器械的工业赞助研究是否具有更有利的结果,以及在偏倚风险方面是否有所不同。本综述是对以前 Cochrane 综述的更新。
在本次更新中,我们检索了 MEDLINE 和 Embase(2010 年至 2015 年 2 月)、Cochrane 方法学注册库(2015 年第 2 期)和 Web of Science(2015 年 6 月)。我们纳入了定量比较制药或医疗器械工业赞助的原始研究与其他来源赞助的研究的实证研究。两名评估员纳入论文、提取数据并评估偏倚风险。结果包括有利结果、有利结论、效应量、偏倚风险以及结论是否与结果一致。
本更新纳入了 27 篇额外的论文(综述现包括 75 篇论文)。与非工业赞助的研究相比,工业赞助的研究更常出现有利的疗效结果,RR:1.27(95%CI 1.17-1.37),不良结果 RR 无差异:1.37(95%CI 0.64-2.93),更常出现有利的结论 RR:1.34(95%CI 1.19-1.51)。19 篇论文报告了赞助和疗效效应量,但由于数据报告和结果异质性的差异,无法进行汇总。比较工业和非工业赞助的研究,我们没有发现随机序列生成、分配隐藏、随访和选择性结果报告方面的偏倚风险存在差异。然而,与非工业赞助的研究相比,工业赞助的研究在盲法方面更常具有低偏倚风险,RR:1.25(95%CI 1.05-1.50)。
与其他来源赞助的研究相比,制药和医疗器械的工业赞助研究具有更有利的疗效结果和结论。