Principal stratum strategy: Potential role in drug development.

  title={Principal stratum strategy: Potential role in drug development.},
  author={Bj{\"o}rn Bornkamp and Kaspar Rufibach and Jianchang Lin and Yuelin Liu and Devan V. Mehrotra and Satrajit Roychoudhury and Heinz Schmidli and Yue Shentu and Marcel Wolbers},
  journal={Pharmaceutical statistics},
A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristics. Often, however, clinical questions also arise regarding the treatment effect in subpopulations of patients, which would experience clinical or disease related events post-randomization. Events that occur after treatment initiation and potentially affect the interpretation or the existence of the measurements are… Expand
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