Journal article
Adaptive Design: Results of 2012 Survey on Perception and Use
Drug information journal, Vol.48(4), pp.473-481
07/01/2014
DOI: 10.1177/2168479014522468
Abstract
Adaptive designs are increasingly used in clinical trials. The Drug Information Association's Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among regulatory agencies, academia, and pharmaceutical and biotech companies to further the science of adaptive clinical development. Results of an ADSWG 2012 survey illustrate that industry and academia are showing more enthusiasm for adaptive trials, accompanied by an increase in the number of trials using designs described as less well understood in the FDA draft guidance on adaptive designs, published in 2010. The increased use of these methods in exploratory trials is consistent with the FDA draft guidance. The survey also identified several examples of successful marketing applications supported by confirmatory trials utilizing adaptive designs that were considered, at least at the time of the draft guidance, as less well understood. Organizations can help overcome these barriers through education, preplanning, and early engagement in discussions with the regulators.
Details
- Title: Subtitle
- Adaptive Design: Results of 2012 Survey on Perception and Use
- Creators
- Caroline Claire MorganSusan HuyckMartin JenkinsLi ChenAlun BeddingChristopher S CoffeyBrenda GaydosJ Kyle Wathen
- Resource Type
- Journal article
- Publication Details
- Drug information journal, Vol.48(4), pp.473-481
- Publisher
- Springer Nature B.V
- DOI
- 10.1177/2168479014522468
- ISSN
- 2168-4790
- eISSN
- 2164-9200
- Language
- English
- Date published
- 07/01/2014
- Academic Unit
- Biostatistics
- Record Identifier
- 9984213369902771
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