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

Nir Balaban, Ghulam Rehman Mohyuddin, Adi Kashi, Amir Massarweh, Gal Markel, David Bomze, Daniel A. Goldstein, Tomer Meirson*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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: New England Journal of Medicine, , and Journal of the American Medical Association. Main outcome measures: 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.

Original languageEnglish
Article number077329
JournalThe BMJ
DOIs
StatePublished - 14 Dec 2023

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