Utilities and challenges of adaptive designs in drug development

TitleUtilities and challenges of adaptive designs in drug development
Publication TypePresentation
Year of Publication2011
AuthorsHung, H M. James
KeywordsSymposium I

In the recent decade statistical literature is enriched by a good number of adaptive design methods for clinical trials. Though conventional non-adaptive designs have many good design properties, application of these designs to learning trials frequently results in limited information to guide the planning of pivotal evidence-setting trials. Adaptive designs may be considered in a hope of providing a better option for learning. Nonetheless, many proposals are made to consider adaptive designs for use in evidence-setting trials. This presentation will focus on the essence of adaptive designs and their utilities and challenges. Case examples are used for illustration.