Clinical trial transparency is under growing threat due to increasing redactions in published research protocols. Redactions, often justified by industry sponsors as necessary to protect sensitive commercial information, have escalated dramatically over the past decade. This study, focusing on phase 3 randomized clinical trials, investigates the scale of this trend and its potential future implications.
According to the researchers, the practice of redacting trial protocols has become especially prevalent in industry-funded trials. Between 2010 and 2021, the rate of redactions in published protocols increased from 0% to 60.8%. Most of these redactions occur in the statistical analysis section, specifically the statistical analysis plan, where companies claim to protect proprietary methods and calculations.
Nir Balaban, one of the lead researchers, explains, “We’ve seen an alarming rise in the amount of redacted text in trial protocols, especially in those funded by industry. The statistical analysis sections, which are crucial for interpreting the trial’s results, are often the most heavily concealed.”
By applying mathematical models to redaction patterns, the research team projects a future scenario they call “RAPTURE,” where all trial protocols will be fully redacted. If current trends continue, RAPTURE could occur between 2073 and 2136, at which point scientific transparency would be gravely compromised.
“Imagine a world where clinical trials exist, but no one can access their protocols,” says Tomer Meirson, another key contributor to the study. “The implications for science are profound. Researchers won’t be able to replicate or validate findings, and regulatory bodies will face significant challenges in approving new treatments.”
Despite these dire predictions, there are early signs that the trend may slow. Data from 2022 and 2023 indicate a slight decrease in the extent of redactions. However, the researchers caution against premature optimism, noting that the drop could be a temporary anomaly. “We don’t want to overstate the significance of the recent decline in redactions,” adds Balaban. “While it’s a positive sign, the broader trend is still concerning.”
The researchers call for a multipronged strategy to combat the rise of protocol redactions. They suggest that academic journals should refuse to publish trials without full protocol transparency, and regulatory agencies could mandate that unredacted protocols be made publicly available. “Science thrives on transparency,” says Meirson. “If we lose access to the methods behind clinical trials, we lose the foundation of scientific inquiry.”
The study’s findings raise serious questions about the future of clinical research. If redactions continue to rise, the very nature of evidence-based medicine may be at risk.
Balaban emphasizes, “We need to act now. By the time RAPTURE becomes a reality, it will be too late. The integrity of science depends on open access to research protocols, and we cannot afford to let commercial interests stand in the way.”
Citation:
Balaban N, Mohyuddin GR, Kashi A, et al. Projecting complete redaction of clinical trial protocols (RAPTURE): redacted cross sectional study. BMJ. 2023;383. doi:10.1136/bmj-2023-077329.
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