Cox regression methods for two-stage randomization designs.

  title={Cox regression methods for two-stage randomization designs.},
  author={Yuliya V Lokhnygina and Jeffrey D. Helterbrand},
  volume={63 2},
Two-stage randomization designs (TSRD) are becoming increasingly common in oncology and AIDS clinical trials as they make more efficient use of study participants to examine therapeutic regimens. In these designs patients are initially randomized to an induction treatment, followed by randomization to a maintenance treatment conditional on their induction response and consent to further study treatment. Broader acceptance of TSRDs in drug development may hinge on the ability to make appropriate… CONTINUE READING

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