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Benefits, Challenges and Obstacles of Adaptive Clinical Trial Designs by Shein-Chung Chow; Ralph Corey is a Biochemistry, Genetics and Molecular Biology article available to read on EtoBox.

What is Benefits, Challenges and Obstacles of Adaptive Clinical Trial Designs about?

In recent years, the use of adaptive design methods in pharmaceutical/clinical research and development has become popular due to its flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation. The flexibility and efficiency, however, increase the risk of operational biases with resulting decrease in the accuracy and reliability for assessing the treatment effect of the test treatment under investigation. In its recent draft guidance, the United States Food and Drug Administration (FDA) expresses regulatory concern of controlling the overall type I error rate at a pre-specified level of significance for a clinical trial utilizing adaptive design. The FDA classifies adaptive designs into categories of well-understood and less well-understood designs. For those less well-understood adaptive designs such as adaptive dose finding designs and two-stage phase I/II (or phase II/III) seamless adaptive designs, statistical methods are not well established and hence should be used with caution. In practice, misuse of adaptive design methods in clinical trials is a concern to both clinical scientists and regulatory agencies. It i

Who reads Benefits, Challenges and Obstacles of Adaptive Clinical Trial Designs?

Author

Shein-Chung Chow; Ralph Corey

Publisher

BioMed Central; Springer (Biomed Central Ltd.); [London]: BioMed Central, 2006-; Springer Science and Business Media LLC; Society for Mining, Metallurgy and Exploration Inc. (ISSN 1750-1172)

Published

2011

Language

EN

Field

Biochemistry, Genetics and Molecular Biology (Life Sciences)