1 / 5

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?

mavisr
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related