A new tool to identify problematic trials is now available, enabling researchers to check whether studies are trustworthy before including them in systematic reviews.

What is INSPECT-SR?

The INSPECT-SR tool (INveStigating ProblEmatic Clinical Trials in Systematic Reviews) was created by an international group of researchers to address the risks posed by untrustworthy randomized controlled trials (RCTs).

Problematic studies, including those affected by human error or research misconduct, can distort the evidence base that systematic reviews rely on, and in turn influence treatment guidelines. This can lead to misleading or even harmful recommendations. One of the most well-known examples of problematic studies was around claims the drug Ivermectin, hailed as a miracle drug that would save the lives of people with severe COVID-19. However, some of the trials used in the systematic reviews were not authentic, according to health authorities in the US, UK and EU. Subsequent high-quality trials suggested little or no benefit.

Until now, reviewers have had no way to assess the trustworthiness of trials based on consensus and validated methods. The INSPECT-SR tool fills this gap by providing a rigorously developed, systematic, and transparent method. 

Developed by researchers at the University of Manchester and Cochrane, working 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
• study results
   

How will INSPECT-SR be used?

Developed in collaboration with the global systematic review community, INSPECT-SR provides reviewers a practical tool to protect evidence syntheses from distortion and ensure more reliable healthcare guidance.

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.

– Dr Jack Wilkinson, University of Manchester

Unlike tools that assess risk of bias or methodological quality, INSPECT-SR focuses specifically on the trustworthiness of trial data without assuming misconduct, and without requiring proof of deliberate wrongdoing.

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. INSPECT-SR will also be added to the resources available for determining whether Cochrane systematic reviews have concerns about studies included in their systematic reviews of health interventions. It has been submitted for formal Cochrane endorsement, with more details expected before the end of 2025. 

The paper INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials is available on medRxiV. More detailed guidance on using the tool is free to access here.