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FDA Public Workshop on Brain Tumor Clinical Trial Endpoints
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Category : Health » Brain Cancer
History and Goals of Cancer Drug Approval Endpoints Project pertain to primary brain cancer. Dr. Ballman will discuss different measures of response,
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Content Summary :
Workshop Purpose The purpose of the Public Workshop on Brain Tumor Clinical Trial Endpoints is to engage in a thorough discussion of the pros and cons of a variety of endpoints for trials intended to support the approval of new drugs to treat primary brain tumors. The goal is to work toward the establishment of a set of principles on current and future standards of efficacy for these drugs. The primary focus will be on endpoints that are ready for incorporation into clinical trials now or in the near future. Workshop participants may identify key issues and areas in which knowledge is limited and may recommend issues or questions for further study. However, it is not the workshop panel’s task to make recommendations or arrive at definitive conclusions. By law, FDA may take advice only from its statutory advisory committees.
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