OEWG Kick-Off Meeting Meg Mooney, MD Chief, Clinical Investigations Branch CTEP, DCTD, NCI – March 24, 2010 CTEP & Cooperative Group Plans for OEWG Implementation: Group Treatment Trials

Overview of CTEP/Group Implementation Plan Funding for Cooperative Group Action Plans – RAPID Establishment of Standing Working Group with Cooperative Group Representatives Concepts, SCs & Consensus Evaluations, CTEP Protocol Consensus Reviews How Do We Set Up a Protocol Timeline that Prioritizes Key Activities? How & When Do We Include Industry Representatives? How Do We Define Allowable Time-Outs? Other Issues?

RaPID – Re-engineering Protocol Implementation and Development All Cooperative Groups have approved funding plans – Each Group’s plan is unique but most have received support for protocol coordinators, officers, and/or medical writers – Most have also received support for IT tools to coordinate Group work – Funding to be awarded in April 2010 Previous ARRA funding provided via ADOPT for IT projects to facilitate rapid protocol development and data management

Standing Working Group for Implementation Establishment of Working Group to discuss & monitor process with recommendations for changes and adjustments Representation from each Cooperative Group  ACOSOG – Susan Budinger  ACRIN – Charlie Apgar  CALGB – Kathy Karas  COG – TBD  ECOG – Jean MacDonald  GOG – Kia Neff  NCCTG – Aimee Tillman  NCIC-CTG – Anna Sudura  NSABP – Walt Cronin  RTOG – Wilma Hoffman  SWOG –Dana Sparks

Concepts, SC / Consensus Evaluations, Protocol Consensus Reviews for Group Trials Specific Issues: ? Page Limit for Concepts (5 to 7 page limit) Schedule for Conference Calls for Concepts that are given a status of “Pending” - Need for set dates/times given # of SCs and need for calls within business hours Concept Consensus Evaluation from SCs are usually all major issues; however, recommendations for secondary objectives (e.g., QOL, correlative science) if not essential components will be recommendations at this stage Protocol Consensus Reviews: CTEP template to be used; potential benefit of comments placed directly into protocol document (?)

How Do We Set Up a Protocol Timeline that Prioritizes Key Activities? Specific Issues: Ongoing Conference Calls – especially for Phase 3 studies? What are the essential elements from Group perspective? Is it possible to compartmentalize certain components, especially secondary endpoints (even defer to amendments after activation if they cannot be accomplished in the targeted timeline)

How Do We Define Allowable Time-Outs? Specific Issues: Already defined: – FDA Review for Phase 3 Registration Trials (as well as early phase clinical trials, as needed) – Industry Review and Approval & Drug Commitment – IRB Review and Approval – Drug Supply Availability Possible Additional “Allowable” Timeouts: – BIQSFP application for an “integral” marker if submitted prior to concept approval – CTSU preparation for opening trial on menu (OPEN) – Other (what do Groups see as possible “allowable” time-outs?) Post-meeting update: IRB review and CTSU placement are no longer considered time-outs. Please see the Time-Out SOP for what constitutes a time-out.

OEWG Kick-Off Meeting Steve Friedman & Meg Mooney, MD Chief, Clinical Investigations Branch CTEP, DCTD, NCI – March 24, 2010 Timeline Tracking (Implementation and Management of Timeouts)

Timeline Tracking - Discussion What Do We Need to Know/Collect from Groups during the Protocol Development Process (Additions to Tracking?) especially with respect to current status of document & reasons for delays? What Type of “Reminder” Systems / Processes Do We Need? GENERAL DISCUSSION Other Issues & Next Steps?