Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints

SERTDEMİR Y. , Burgut R.

CONTEMPORARY CLINICAL TRIALS, cilt.30, ss.8-12, 2009 (SCI İndekslerine Giren Dergi) identifier identifier identifier

  • Cilt numarası: 30 Konu: 1
  • Basım Tarihi: 2009
  • Doi Numarası: 10.1016/j.cct.2008.08.006
  • Sayfa Sayıları: ss.8-12


Background: In recent years the use of surrogate end points (S) has become an interesting issue. In clinical trials, it is important to get treatment outcomes as early as possible. For this reason there is a need for surrogate endpoints (S) which are measured earlier than the true endpoint (T). However, before a surrogate endpoint can be used it must be validated. For a candidate surrogate endpoint, for example time to recurrence, the validation result may change dramatically between clinical trials. The aim of this study is to show how the validation criterion (R-trial(2)) proposed by Buyse et al. are influenced by the magnitude of treatment effect with an application using real data.