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NCI Workshop on Phase ‘0’ Trials: Rationale and Goals

NCI Workshop on Phase ‘0’ Trials: Rationale and Goals. Reduce the FDA’s Exploratory IND to practice: New process for investigators interested in early phase cancer therapeutics. Designed for pilot studies from Academia and Pharma. When appropriate? When not?

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NCI Workshop on Phase ‘0’ Trials: Rationale and Goals

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  1. NCI Workshop on Phase ‘0’ Trials:Rationale and Goals • Reduce the FDA’s Exploratory IND to practice: New process for investigators interested in early phase cancer therapeutics. Designed for pilot studies from Academia and Pharma. • When appropriate? When not? • How to apply it? Who can help you? • What are pitfalls? What has been learned? • Can it speed up the development timeline? GOAL: Provide primer on a new mechanism for testing novel therapeutic and imaging molecules

  2. NCI Workshop on Phase ‘0’ Trials:Format • Introductory lectures and overviews in the morning. Coffee and Lunch on your own. • “Hands-On” panels and “Think-Tank” question and answer sessions in the afternoon: Will provide you with question cards that will be picked up after the morning session so that they can be addressed after lunch. Please identify yourself when speaking. Informal: Focus on providing information that will assist you in the conduct of very early phase cancer clinical trials

  3. The Next Speaker is:Dr. David Jacobson-Kram

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