ArticleBMJ (Clinical research ed.)2023
Projecting complete redaction of clinical trial protocols (RAPTURE): redacted cross sectional study.
Article in BMJ (Clinical research ed.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesTo characterise redactions in clinical trials and estimate a time when all protocols are fully removed (RAPTURE).
designRedacted cross sectional study.
settingPublished phase 3 randomised controlled trials from 1 January 2010 to ██████████████.
participants
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.
conclusionsThis 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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