Adaptive Designs in Clinical Drug Development: Opportunities, Challenges, and Scope Reflections Following PhRMA's November 2006 Workshop

This paper provides reflections on the opportunities, scope and challenges of adaptive design as discussed at PhRMA's workshop held in November 2006. We also provide a status report of workstreams within PhRMA's working group on adaptive designs, which were triggered by the November worksh...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2007-11, Vol.17 (6), p.957-964
Main Authors: Krams, Michael, Burman, Carl-Fredrik, Dragalin, Vladimir, Gaydos, Brenda, Grieve, Andrew P., Pinheiro, Jose, Maurer, Willi
Format: Article
Language:English
Subjects:
Adaptive design
Clinical trial
Clinical Trials as Topic - methods
Clinical Trials as Topic - statistics & numerical data
Clinical Trials Data Monitoring Committees
Data Interpretation, Statistical
Drug development
Drug Industry
Humans
Research Design
United States
United States Food and Drug Administration
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Summary:This paper provides reflections on the opportunities, scope and challenges of adaptive design as discussed at PhRMA's workshop held in November 2006. We also provide a status report of workstreams within PhRMA's working group on adaptive designs, which were triggered by the November workshop. Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543400701643764