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Published on: September 20, 2019
Projecting complete redaction of clinical trial protocols (RAPTURE): redacted cross sectional study
Nir Balaban1, Ghulam Rehman Mohyuddin2, Adi Kashi1
1Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
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.
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