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预测临床试验方案的完全删减（RAPTURE）：删减的横断面研究。

Projecting complete redaction of clinical trial protocols (RAPTURE): redacted cross sectional study.

机构信息

Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Division of Hematology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.

出版信息

BMJ. 2023 Dec 14;383:e077329. doi: 10.1136/bmj-2023-077329.

DOI:10.1136/bmj-2023-077329
PMID:38097263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10719744/
Abstract

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

, █, and .

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.

摘要

目的

描述临床试验中的删减内容，并估计所有方案完全删除的时间（RAPTURE）。

设计

删减的横断面研究。

设置

2010 年 1 月 1 日至 ██████████████ 期间发表的 3 期随机对照试验。

参与者

， ， 。

主要观察结果

█████ ████████ ██████████████ ██████ ██████████ ████████ ████████ ██████████ ███████████ ████████████ ████████████ ████████████████████████ ██████████████████ 结果：符合纳入标准的 ████████████████████ 研究方案有 268 个（56.7%），可获取。方案中的删减率从 2010 年的 0 增加到 2021 年的 60.8%（P<0.001）。数据删减的程度也有所增加，行业资助试验的平均累计删减量从 2010 年的 0 增加到 2021 年的 3.5 页（P<0.001）。模型预测 RAPTURE 预计将发生在 2073 年至 2136 年之间。删减主要出现在 ████████ 赞助的试验中，主要发生在统计设计中。

结论

本研究强调了方案删减的增加，并预测，在 2073 年至 2136 年之间， ██████████████████████████████████████████ 将完全删减。删减的合理理由可能会被发现。需要采取多管齐下的策略来防止方案删减，以维护科学的完整性。

可及性

本文部分删减，但为了 ███████████，可在补充材料中找到无删减版本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/32cd40e038da/baln077329.f10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/32cd40e038da/baln077329.f10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/591019759da0/baln077329.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/509b57b61025/baln077329.f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/1ae97ea7c538/baln077329.f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/3653981845c0/baln077329.f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/3356dec2e046/baln077329.f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/8024589d25f4/baln077329.f7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/8db29acd0340/baln077329.f8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/9bc0822aa412/baln077329.f9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/32cd40e038da/baln077329.f10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/32cd40e038da/baln077329.f10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/591019759da0/baln077329.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/509b57b61025/baln077329.f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/1ae97ea7c538/baln077329.f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/3653981845c0/baln077329.f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/3356dec2e046/baln077329.f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/8024589d25f4/baln077329.f7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/8db29acd0340/baln077329.f8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/9bc0822aa412/baln077329.f9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/10719744/32cd40e038da/baln077329.f10.jpg

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