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质疑生物制剂和小分子药物治疗类风湿关节炎的行业资助与非行业资助随机对照试验之间的发表偏倚。

Questioning a publication bias between industry-funded and non-industry-funded randomized controlled trials on biological and small molecule therapy for rheumatoid arthritis.

机构信息

Division of Pediatric Emergency Medicine, Dana Duek Children's Hospital, Tel Aviv Medical Center, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv, 6423906, Israel.

Department of Pediatrics, Dana Duek Children's Hospital, Tel Aviv Medical Center, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Israel.

出版信息

Semin Arthritis Rheum. 2020 Feb;50(1):7-11. doi: 10.1016/j.semarthrit.2019.06.006. Epub 2019 Jun 8.

Abstract

BACKGROUND

There has been a significant increase in financial support of clinical research by the pharmaceutical industry.

METHODS

We performed a comprehensive systematic literature review to determine whether there is publication bias for rheumatoid arthritis (RA) studies between industry-funded and non-industry funded randomized controlled trials (RCTs), and between RCTs with positive results (PRs) and those with negative results (NRs) of FDAapproved biological and small molecule drug therapy for RA. Each RCT was classified as having either a PR or a NR, and as having received commercial funding or not.

RESULTS

Most (297/349, 85.18%) of the RCTs were commercially funded. There was no significant difference in PRs or association with publication between commercially and noncommercially funded RCTs. Sample size was significantly larger in commercially funded RCTs and in those with PRs, and it was the only significant parameter that predicted publication in higher impact factor journals in the field of RA.

CONCLUSION

There is no significant association between commercial funding and the publication of positive results or the publication of an RCT in higher impact factor journals.

摘要

背景

制药业对临床研究的财政支持显著增加。

方法

我们进行了全面的系统文献综述,以确定在类风湿关节炎(RA)研究中,行业资助和非行业资助的随机对照试验(RCT)之间,以及美国食品和药物管理局(FDA)批准的生物和小分子药物治疗 RA 的阳性结果(PR)和阴性结果(NR)的 RCT 之间是否存在发表偏倚。每个 RCT 被归类为具有 PR 或 NR,以及是否接受商业资助。

结果

大多数(349 项 RCT 中的 297 项,85.18%)为商业资助。商业和非商业资助的 RCT 之间在 PR 或与发表的关联方面没有显著差异。商业资助的 RCT 和 PR 的 RCT 样本量明显更大,这是唯一能够预测 RA 领域高影响因子期刊发表的重要参数。

结论

商业资助与阳性结果的发表或 RCT 在高影响因子期刊上的发表之间没有显著关联。

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