Journal of the Formosan Medical Association
Volume 107, Issue 12, Supplement , Pages S3-S8, December 2008

A Regulatory View of Adaptive Trial Design

  • Mey Wang

      Affiliations

    • Division of Clinical Sciences, Center for Drug Evaluation, Taipei Medical University, Taipei, Taiwan
    • Institute of Injury Prevention and Control, Taipei Medical University, Taipei, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Mey Wang, Division of Clinical Sciences, Center for Drug Evaluation, 1/F, No. 15-1, Section 1, Hangjou South Road, Taipei, Taiwan
    • ,
  • Ya-Chi Wu

      Affiliations

    • Division of Clinical Sciences, Center for Drug Evaluation, Taipei Medical University, Taipei, Taiwan
    • ,
  • Guei-Feng Tsai

      Affiliations

    • Division of Clinical Sciences, Center for Drug Evaluation, Taipei Medical University, Taipei, Taiwan

Received 29 August 2008; received in revised form 30 September 2008; accepted 8 October 2008.

Article Outline

Developing a new medicine is an expensive and time-consuming process. Researchers are interested in applying better designs to expedite the approval of potential medicinal products. Adaptive designs, which allow for some types of prospectively planned mid-study change, can improve the efficiency of a trial and maximize the chance of success. Possible design adaptations of clinical trials include sample size re-estimation, change in primary endpoint, interim dropping of treatment arms, change in statistical hypothesis, and change in the primary analysis. In this article, the regulatory considerations of the methodological issues with respect to adaptive design are discussed. Several examples of design adaptation that the Center for Drug Evaluation has encountered during the past 3 years are presented.

Key Words:  adaptive design , dropping treatment arm , primary analysis , primary endpoint

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PII: S0929-6646(09)60002-4

doi:10.1016/S0929-6646(09)60002-4

Journal of the Formosan Medical Association
Volume 107, Issue 12, Supplement , Pages S3-S8, December 2008

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