New tool helps researchers spot problematic trials before they distort evidence

by Cochrane

edited by Gaby Clark, reviewed by Andrew Zinin

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Problematic studies, including those affected by human error or research misconduct, can distort the evidence that systematic reviews rely on and, in turn, influence treatment guidelines. This can lead to inaccurate or even harmful recommendations. A recent example was a review of ivermectin for the treatment of COVID-19. Some of the trials used in the systematic reviews were not authentic, according to health authorities in the U.S., U.K. and EU. Subsequent high-quality trials suggested little or no benefit.

Problems with a trial can go unrecognized for years, and many trials are never formally retracted, making the true scale of the issue hard to pin down. Reviewers have historically had only limited, inconsistent ways to assess trial trustworthiness. The INSPECT-SR tool fills that gap with a rigorously developed, systematic and transparent method.

Developed by researchers at the University of Manchester, Cochrane and the University of Colorado, in collaboration with more than 40 institutions worldwide, INSPECT-SR guides reviewers through 21 structured checks across four domains: post-publication notices; study conduct, governance and transparency; text and figures; and study results. The work is published in BMJ.

Dr. Jack Wilkinson, lead researcher, said, "More than 150 integrity and health research experts from around the world have contributed to the development of INSPECT-SR. Researchers can use this tool to assess the trustworthiness of randomized controlled trials and to identify problematic studies, knowing that it has the backing of the systematic review community."

Unlike tools that assess risk of bias or methodological quality, INSPECT-SR focuses specifically on the trustworthiness of trial data. The framework does not assume misconduct or imply deliberate wrongdoing, but it can help identify fraudulent studies among other problematic trials. The research team encourages reviewers, guideline developers and publishers to adopt INSPECT-SR and anticipates that it will become the standard for assessing the trustworthiness of RCTs.

"Systematic reviews are only as credible as the studies they include," said Lisa Bero, a fellow author from the University of Colorado and Cochrane senior research integrity editor. "INSPECT-SR gives reviewers a rigorous, thoroughly tested, transparent way to detect problematic trials, helping to safeguard the integrity of evidence that informs patients, clinicians and policymakers."

INSPECT-SR is freely available for anyone to use from launch. It has already been endorsed for use in Cochrane reviews and added to the resources Cochrane review teams draw on when assessing whether included studies raise integrity concerns.

Publication details

INSPECT-SR: a tool for assessing trustworthiness of randomized controlled trials, BMJ (2026). DOI: 10.1136/bmj-2026-100611

Journal information: British Medical Journal (BMJ)

Provided by Cochrane Who's behind this story?

Gaby Clark

MA in English, copy editor since 2021 with experience in higher education and health content. Dedicated to trustworthy science news. Full profile →

Andrew Zinin

Master's in physics with research experience. Long-time science news enthusiast. Plays key role in Science X's editorial success. Full profile →

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