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

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: █████ ████████ ██████████████ ██████ ██████████ ████████ ████████ ██████████ ███████████ ████████████ ████████████ ████████████████████████ ██████████████████ 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.