Brannath, Werner, Burger, Hans Ulrich, Glimm, Ekkehard, Stallard, Nigel, Vandemeulebroecke, Marc and Wassmer, Gernot. (2010) Comments on the draft guidance on “Adaptive design clinical trials for drugs and biologics” of the U.S. Food and Drug Administration. Journal of Biopharmaceutical Statistics, Vol.20 (No.6). pp. 1125-1131. ISSN 1054-3406

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Abstract

The U.S. FDA has published a draft guidance on oAdaptive Design Clinical Trials for Drugs and Biologicso, which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within the joint working group oAdaptive Designs and Multiple Testing Procedureso of the Austro-Swiss and German regions of the International Biometric Society held at the 90-day public comment period in spring 2010.

Item Type:	Journal Article
Subjects:	Q Science > QA Mathematics R Medicine > R Medicine (General) R Medicine > RS Pharmacy and materia medica
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials -- Design, United States. Food and Drug Administration, Biologicals -- Testing, Drugs -- Testing, Drug development
Journal or Publication Title:	Journal of Biopharmaceutical Statistics
Publisher:	Taylor & Francis Inc.
ISSN:	1054-3406
Official Date:	2010
Volume:	Vol.20
Number:	No.6
Number of Pages:	7
Page Range:	pp. 1125-1131
Identification Number:	10.1080/10543406.2010.514453
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Description:	Special Issue: Special theme for adaptive clinical trial design
URI:	http://wrap.warwick.ac.uk/id/eprint/4890

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