Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.

@article{Ciani2014ValidationOS,
  title={Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.},
  author={Oriana Ciani and Sarah Davis and Paul Tappenden and Richard Garside and Ken Stein and Anna J Cantrell and Everardo Delforge Saad and Marylou Buyse and Ramona Leigh Taylor},
  journal={International journal of technology assessment in health care},
  year={2014},
  volume={30 3},
  pages={
          312-24
        }
}
OBJECTIVES Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how… CONTINUE READING
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