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In clinical trials, surrogate endpoints are frequently used as substitute measures for direct clinical outcomes. However, the use of these surrogates often lacks consistency and transparency. To address this, researchers have developed a SPIRIT-Surrogate extension checklist. This tool aims to standardize the reporting of surrogate endpoints in randomized controlled trial protocols.
“We wanted to improve the quality of reporting for these surrogate measures, ensuring that trials using these endpoints are more reliable and transparent,” says one of the lead authors.
Importance of the SPIRIT-Surrogate Checklist
The SPIRIT-Surrogate extension is built upon the original SPIRIT initiative, which provides guidelines for protocol development in clinical trials. By extending this framework to cover surrogate endpoints, the checklist fills a crucial gap in clinical trial reporting.
“Surrogate outcomes can be extremely valuable, but only if they are used and reported correctly,” the researchers explain. Without this standardization, surrogate measures can lead to misinterpretation of trial results, potentially affecting clinical decisions.
Ensuring Transparency in Clinical Trials
One of the key objectives of the SPIRIT-Surrogate extension is to foster greater transparency in how surrogate endpoints are selected and reported. The checklist includes detailed guidance on the justification for using surrogate outcomes, statistical methods for validation, and the relationship between surrogate endpoints and true clinical outcomes.
The authors emphasize, “The extension helps ensure that surrogate outcomes are not only clearly justified but also aligned with the broader objectives of the clinical trial.”
Real-World Application and Future Impact
The authors believe the SPIRIT-Surrogate checklist will have far-reaching effects on clinical research. By ensuring more transparent and standardized reporting, it could lead to more reliable and replicable trials. This, in turn, has the potential to significantly improve the development of new medical treatments and interventions.
“Our hope is that this checklist will be widely adopted across the research community,” say the authors. “It will improve the reliability of clinical trials, which is ultimately beneficial for patient care.”
Citation:
Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, et al. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. BMJ. 2023;386. doi:10.1136/bmj-2023-078525.
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