Recommendations for evaluating a single surrogate endpoint (REASSurE): consensus based, surrogate evaluation framework with explanation and elaboration

AI Summary

The REASSurE framework sets out a consensus-based approach for assessing the reliability of a single surrogate endpoint in clinical trials. It addresses the trade-off between faster drug development and the risk that improvements in a surrogate measure may not translate into meaningful patient outcomes.

Surrogate endpoints are often used in lieu of patient relevant outcomes to shorten the duration of clinical trials.123 This decision results from the tension between efficiency and uncertainty in drug development. While the use of a surrogate endpoint may lead to faster approval of a treatment, there is an inherent risk that such a treatment may not provide adequate benefit to patients if a patient relevant outcome had been used to assess its efficacy.4This risk may be alleviated if there is adequate evidence that the effect of the treatment on the surrogate endpoint reliably predicts the effect of the treatment on the patient relevant outcome.35 Conversely, the risk may be increased if there is a lack of evidence, or evidence of poor predictive ability of the surrogate endpoint. Assessment of this risk is part of surrogate endpoint evaluation.67This assessment ultimately matters to the patient; for instance, it is within the...