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 GroupACOSOG – Susan BudingerACRIN – Charlie ApgarCALGB – Kathy KarasCOG – TBDECOG – Jean MacDonaldGOG – Kia NeffNCCTG – Aimee TillmanNCIC-CTG – Anna SuduraNSABP – Walt CroninRTOG – Wilma HoffmanSWOG –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?