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LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010

LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010. James Zwiebel, MD Chief, Investigational Drug Branch CTEP, DCTD, NCI. Timeline pauses if industry negotiations cause delay. LOI. Protocol. LOI. Protocol. Protocol. revision/review and. revision/. review. review.

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LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010

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  1. LOI and Protocol Review ProcessOEWG Kickoff MeetingMarch 23, 2010 James Zwiebel, MD Chief, Investigational Drug Branch CTEP, DCTD, NCI

  2. Timeline pauses if industry negotiations cause delay LOI Protocol LOI Protocol Protocol revision/review and revision/ review review development forms development review 0 30 60 120 150 210 Time (days) OEWG Proposed Timeline for CTEP Phase II Early Drug Development Trial Activation Post-meeting update: Cooperative Group Phase 1/2 or 2 Concepts of > 100 patients have a target timeline of 240 days (210 days + 30 days added to Concept approval stage = 240 days). Fig. 8. Report of the Operational Efficiency Working Group of the Clinical Trials and Translational Research Advisory Committee

  3. What’s included in this evening’s presentation • Unsolicited LOIs • Phase 1 & Phase 2 studies under CTEP IND (Post-meeting note: …as well as treatment trials submitted to CTEP by CTEP/DCTD grantees and contractors, whether or not CTEP holds the IND.) • Includes Cooperative Group studies with <100 pts • Mass solicitation • Includes Cooperative Group studies of any size

  4. Post-meeting update: For the most updated OEWG timelines, please see the Timeline Charts on the OEWG website at http://ctep.cancer.gov/SpotlightOn/OEWG.htm

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