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Projecting complete redaction of clinical trial protocols (RAPTURE): redacted cross sectional study
The BMJ ( IF 105.7 ) Pub Date : 2023-12-14 , DOI: 10.1136/bmj-2023-077329
Nir Balaban , Ghulam Rehman Mohyuddin , Adi Kashi , Amir Massarweh , Gal Markel , David Bomze , Daniel A Goldstein , Tomer Meirson

Objectives To characterise redactions in clinical trials and estimate a time when all protocols are fully removed (RAPTURE). Design Redacted cross sectional study. Setting Published phase 3 randomised controlled trials from 1 January 2010 to ██████████████. Participants New England Journal of Medicine , █ █████████ , and Journal of the American Medical Association . Main outcome measures █████ ████████ ██████████████ ██████ ██████████ ████████ ████████ ██████████ ███████████ ████████████ ████████████ ████████████████████████ ██████████████████ Results ████████████████████ met the inclusion criteria, with 268 (56.7%) research protocols available and accessible. The rate of redactions in protocols has increased from 0 in 2010 to 60.8% in 2021 (P<0.001). The degree of data redaction has also increased, with the average cumulative redactions among industry funded trials rising from 0 in 2010 to 3.5 pages in 2021 (P<0.001). Modelling predicts that RAPTURE is expected to occur between 2073 and 2136. Redactions featured predominantly in ████████ sponsored trials and mostly occurred in the statistical design. Conclusions This study highlights the rise in protocol redactions and predicts that, ██████████████████████████████████████████ will be entirely redacted between 2073 and 2136. A legitimate rationale for the redactions could ███ be found. A multipronged strategy against protocol redactions is required to maintain the integrity of science. Availability This paper is partially redacted, but for the sake of ███████████, a version without any redactions can be found in the supplementary material. Data and fully redacted version of the manuscript are available from the corresponding author (tomermrsn@gmail.com) on reasonable request.

中文翻译:

预计临床试验方案的完整修订(RAPTURE):修订的横断面研究

目标 描述临床试验中修订的特征并估计所有方案完全删除的时间 (RAPTURE)。设计经过编辑的横断面研究。背景 2010 年 1 月 1 日至 ██████████████ 已发布第 3 阶段随机对照试验。参与者《新英格兰医学杂志》、█ █████████ 和《美国医学会杂志》。主要成果指标 █████ ████████ ██████████████ ██████ ██████████ ████ ████ ████████ ██████████ ███████████ ████████████ █████ ███████ ████████████████████████ ██████████████████ 结果████████████████████ 符合纳入标准,有 268 个(56.7%)研究方案可供使用。协议修订率从 2010 年的 0 增加到 2021 年的 60.8%(P<0.001)。数据编辑的程度也有所增加,行业资助的试验的平均累积编辑量从2010年的0上升到2021年的3.5页(P<0.001)。模型预测 RAPTURE 预计发生在 2073 年至 2136 年之间。编辑主要出现在 ████████ 赞助的试验中,并且主要发生在统计设计中。结论 这项研究强调了协议修订的增加,并预测,█████████████████████████████████████ █████ 将在 2073 年至 2136 年间被完全编辑。可以找到 ███ 编辑的合理理由。为了维护科学的完整性,需要采取多管齐下的策略来防止协议修改。可用性本文已部分编辑,但为了███████████,可以在补充材料中找到没有任何编辑的版本。根据合理要求,可从通讯作者 (tomermrsn@gmail.com) 处获取手稿的数据和完全编辑版本。
更新日期:2023-12-14
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