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Implementation of adaptive methods in early phase clinical trials

Published on May 31, 2018   47 min

A selection of talks on Pharmaceutical Sciences

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Hello. My name is Gina Petroni and I am the director of the division of Translational Research and Applied Statistics in the School of Medicine's Department of Public Health Sciences at the University of Virginia. My topic of presentation today is "Implementation of Adaptive Methods in Early Phase Clinical Trials".
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For this talk, I am assuming that there is initial understanding of the phases of clinical research with early phase referring to studies that assess safety and dose finding. In addition, I am assuming there is familiarity with adaptive trial methodology. Both the statistical and medical literature abounds with reviews, justifications and recommendations on the use of more novel designs to efficiently and accurately address the objectives of finding appropriate doses or dose combinations to merit further research. These recommended designs are often referred to as adapted designs and are based upon the premise that as safety and other information are acquired. The whole of the information should be used to guide those recommendations for future study participants. Use of these model-based designs remains infrequent. This can be attributed to several causes including a poor understanding from clinicians and reviewers in how these designs actually work and how best to evaluate the appropriateness of a proposed design. These barriers are likely to be enhanced in the coming years as the recent paradigm of drug development involves a shift to more complex dose finding problems. So the purpose of this talk is not to advocate the use of any particular body of adaptive designs but to provide recommendations on the minimal information that should be included in a protocol to aid in the understanding and approval of the protocol by the various scientific and regulatory committees that review them and to provide guidance on what should be included in order to appropriately conduct the actual protocol specific design.

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Implementation of adaptive methods in early phase clinical trials

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