Table 1 Advantages and risks or limitations of surrogate endpoints put forward by the participants.
Advantages | Risks or limitations |
To reduce trial duration • Accelerate approval and dissemination of effective therapies • More rapidly pass to another question | Use of non validated surrogates Generalization of the results to another setting or patient population |
To decrease the required number of patients | Alteration of the validity after therapeutic advances |
To decrease the cost of the trial | Risk of erroneous conclusion concerning survival (reliability), late toxicity not measured |
Endpoints not confounded by subsequent lines of treatment • Better imputability • Power (sensibility) gain | Limitations regarding the definition and the reproducibility of the surrogate endpoint |
Relevance of the surrogate endpoint in itself | Cost |