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Objective: Traditionally validation of surrogate endpoints has been carriedout using RCT data. However, RCT data may be too limited to validate surrogateendpoints. In this paper, we sought to improve validation of surrogateendpoints with the inclusion of real world evidence (RWE).  Study Design and Setting: We use data from comparative RWE (cRWE) and singlearm RWE (sRWE), to supplement RCT evidence for evaluation of progression freesurvival (PFS) as a surrogate endpoint to overall survival (OS) in metastaticcolorectal cancer (mCRC). Treatment effect estimates from RCTs, cRWE andmatched sRWE, comparing anti-angiogenic treatments with chemotherapy, were usedto inform surrogacy patterns and predictions of the treatment effect on OS fromthe treatment effect on PFS.  Results: Seven RCTs, four cRWE studies and three matched sRWE studies wereidentified. The addition of RWE to RCTs reduced the uncertainty around theestimates of the parameters for the surrogate relationship. Addition of RWE toRCTs also improved the accuracy and precision of predictions of the treatmenteffect on OS obtained using data on the observed effect on PFS.  Conclusion: The addition of RWE to RCT data improved the precision of theparameters describing the surrogate relationship between treatment effects onPFS and OS and the predicted clinical benefit.

Using Bayesian Evidence Synthesis Methods to Incorporate Real World Evidence in Surrogate Endpoint Evaluation