Response-adaptive decision-theoretic trial design: operating characteristics and ethics

Author:

Lipsky Ari M.12,Lewis Roger J.134

Affiliation:

1. Department of Emergency Medicine; Harbor-UCLA Medical Center; Torrance CA U.S.A.

2. Gertner Institute for Epidemiology and Health Policy Research; Tel Hashomer Israel

3. Department of Medicine; David Geffen School of Medicine at UCLA; Los Angeles CA U.S.A.

4. Berry Consultants; LLC.; Austin TX U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference22 articles.

1. Adaptive designs: terminology and classification;Dragalin;Drug Information Journal,2006

2. Overhauling clinical trials;Scott;Nature Biotechnology,2007

3. Adaptive designs in clinical drug development-an executive summary of the PhRMA Working Group;Gallo;Journal of Biopharmaceutical Statistics,2006

4. European Medicines Agency Reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plan (EMEA, London, October 2007) http://www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf

5. Gottlieb S Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration-2006 Conference on Adaptive Trial Design-July 10, 2006 http://www.fda.gov/NewsEvents/Speeches/ucm051901.htm

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