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DIA Global Center

2017 年 11 月 09 日 8:15 上午 - 2017 年 11 月 10 日 3:30 下午

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Adaptive Design in Clinical Trials: When and How to Apply

Case Study 1 and 2

Session Chair(s)

Sandeep  Menon, PhD

Sandeep Menon, PhD

Chief Scientific Officer of Artificial Intelligence and Digital Science and SVP,

Pfizer Inc, United States

Case Study 1
An exploratory two-stage frequentist adaptive design (Maximizing design)

  • Stage 1 is the Proof of Concept phase and Stage 2 the dose-finding phase

Case Study 2
An exploratory two-stage Bayesian adaptive design (NDLM design using SPCD approach)
  • Adaptations are made at the end of Stage 1 and throughout Stage 2 based on a NDLM design with PoC and DF both based on a combined analysis of Treatment Periods 1 and 2 using a SPCD approach

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