CTEP Plans: Consensus Reviews & Templates

1. CTEP Plans:Consensus Reviews& Templates OEWG Kick-Off Meeting March 23, 2010 Andrea Denicoff, MS, RN, ANP Clinical Investigations Branch CTEP, DCTD

2. Objectives • Describe CTEP’s internal changes to improve consensus reviews based on OEWG input • Discuss plans for CTEP to gather feedback • Provide information on protocol templates and improvement plans • Gather your feedback

3. Major Goals to Improve Consensus Reviews • Assist with streamlining CTEP’s protocol review comments • Facilitate PI/Group response to CTEP through identifying major concerns and administrative comments easy to incorporate into protocol. • Act as an intermediary step towards the use of an ePA system

4. Methodology • Examined CTEP reviews and PI/ Group responses to consensus reviews • Invited all branches of CTEP to provide input and feedback on various new review formats and ideas to improve process • Multiple reviewers, including CIB and IDB lead reviewers, suggested and tested various formats and provided feedback • Through field testing of various forms and input, final draft created

5. CTEP Feedback • Major comments should be prioritized and include key scientific issues or a major “show stopper” such as a CRADA problem, agent availability, etc • Where possible, reviewers should use clear and concise language that promotes rapid/simple response from the study site (e.g. change ‘X’ to ‘Y’) • Created column to list protocol section for sorting comments and to facilitate PI/Group response

6. Reviewer Comment Sections Major Issues (Response required) Major areas of concern in the protocol or informed consent Administrative (Response required) Required additions, requested clarifications of the protocol and informed consent, and editorial changes. Recommendations (Response is not required) Recommendations and comments to the PI/Group that CTEP PRC considers may improve the protocol, but is only for PI/Group consideration.

8. Revised Consensus Reviewssent back to PI/Groups • Plans are underway to solicit feedback from PIs/Groups about their use of revised formatting • Once the majority of PIs/Groups have provided input, adjustments will be made to finalize formatting • Future plans: CTEP’s PIO will directly add administrative changes to an unofficial copy of the protocol document that has been specified by the lead reviewer to change using Track Changes™. Plan to pilot test within CTEP to assure quality control, and then pilot test with PIs/Groups that are interested.

9. CTEP Protocol Templates Protocol development information and templates on CTEP web site includes: Forms Generic protocol templates Protocol authoring handbook Policy and guidelines for protocol development Lists of codes and values RECIST criteria CDE Dictionary Data policies Generic informed consent template Correlative science guidelines

10. http://ctep.cancer.gov/protocolDevelopment/templates_applications.htmhttp://ctep.cancer.gov/protocolDevelopment/templates_applications.htm

11. Protocol Development Protocol development information that is included with each LOI/Concept approval: Agent specific protocol template (if available) Appropriate CAEPR(s) Appropriate pharmaceutical data sheet(s) Appropriate Investigators Brochures

12. Plans for CTEP Templates • CTEP will provide up to date agent-specific protocol templates available for agents involved in mass solicitations • A secure web site to place confidential agent templates needed for protocols is under investigation

13. Questions & Your input