Adaptive Design: A Review of the Technical, Statistical, and Regulatory Aspects of Implementation in a Clinical Trial

Franck Pires Cerqueira, Ângelo Jesus, Maria Dulce Cotrim

Type: Review

Publication Date: 2019-02-27

Citations: 3

DOI: https://doi.org/10.1177/2168479019831240

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Therapeutic Innovation & Regulatory Science - View
The Scientific Repository of the Polytechnic Institute of Porto (Polytechnic Institute of Porto) - View - PDF

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+	A Design for Testing Clinical Strategies: Biased Adaptive Within-Subject Randomization	2000	Phillip W. Lavori Ree Dawson
+	Optimality, Variability, Power	2003	Feifang Hu William F. Rosenberger
+	Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group	2006	Paul Gallo Christy Chuang‐Stein Vladimir Dragalin Brenda Gaydos Michael Krams José Cirı́aco Pinheiro
+	Adaptive clinical trials in oncology	2011	Donald A. Berry
+	Challenges in Implementing Adaptive Designs: Comments on the Viewpoints Expressed by Regulatory Statisticians	2006	Paul Gallo Willi Maurer
+	Statistical Considerations for Testing Multiple Endpoints in Group Sequential or Adaptive Clinical Trials	2007	Hung Hung Sue‐Jane Wang Robert T. O’Neill
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+	Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration	2010	Werner Brannath Hans Ulrich Burger Ekkehard Glimm Nigel Stallard Marc Vandemeulebroecke Gernot Wassmer