Research Christmas 2023: Marginal Gains

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

Nir Balaban, Ghulam Rehman Mohyuddin, Adi Kashi, et al

BMJ 2023; 383 doi: https://doi.org/10.1136/bmj-2023-077329 (Published 14 December 2023)Cite this as: BMJ 2023;383:e077329

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.

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 1 January
2022.
Participants New England Journal of Medicine, The Lancet, and Journal of the American
Medical Association.
Main outcome measures Amount and nature of redactions and prediction of the time of
complete protocol concealment; that is, the date of complete removal of amendments and
protocols of trials using redactions (RAPTURE).
Results 473 phase 3 randomised controlled trials 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 industry sponsored trials and
mostly occurred in the statistical design.
Conclusions This study highlights the rise in protocol redactions and predicts that, at the rate
of redaction up to 2021, protocols will be entirely redacted between 2073 and 2136. A
legitimate rationale for the redactions could not 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 transparency, a version
without any redactions can be found in the supplementary material.