Using Bayesian Evidence Synthesis Methods to Incorporate Real World Evidence in Surrogate Endpoint Evaluation
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以贝叶斯证据综合纳入真实世界证据评估替代终点
- 研究问题
- 随机试验证据有限时，纳入比较性及匹配后的单臂真实世界证据，能否改善无进展生存期对总生存期的替代关系评估？
- 方法与思路
- 作者用贝叶斯证据综合汇集随机试验、比较性真实世界研究和匹配单臂研究的处理效应，预测转移性结直肠癌的总生存期效应。
- 材料陈述的贡献
- 摘要称加入真实世界证据后，替代关系参数的不确定性下降，并提高由无进展生存期处理效应预测总生存期效应的准确性与精度。
- 阅读关注点
- 应核对不同证据来源的可比性、单臂匹配和偏差处理，以及预测准确性的验证方式与替代关系跨研究可迁移的条件。
- 阅读边界
- 所给版本为 arXiv 预印本，同行评审及期刊接收未核实；摘要未说明完整模型、偏差控制假设或预测改善的数值幅度。
原文摘要
Objective: Traditionally validation of surrogate endpoints has been carried out using RCT data. However, RCT data may be too limited to validate surrogate endpoints. In this paper, we sought to improve validation of surrogate endpoints with the inclusion of real world evidence (RWE). Study Design and Setting: We use data from comparative RWE (cRWE) and single arm RWE (sRWE), to supplement RCT evidence for evaluation of progression free survival (PFS) as a surrogate endpoint to overall survival (OS) in metastatic colorectal cancer (mCRC). Treatment effect estimates from RCTs, cRWE and matched sRWE, comparing anti-angiogenic treatments with chemotherapy, were used to inform surrogacy patterns and predictions of the treatment effect on OS from the treatment effect on PFS. Results: Seven RCTs, four cRWE studies and three matched sRWE studies were identified. The addition of RWE to RCTs reduced the uncertainty around the estimates of the parameters for the surrogate relationship. Addition of RWE to RCTs also improved the accuracy and precision of predictions of the treatment effect on OS obtained using data on the observed effect on PFS. Conclusion: The addition of RWE to RCT data improved the precision of the parameters describing the surrogate relationship between treatment effects on PFS and OS and the predicted clinical benefit.