1. NCCCP Pilot – Clinical Trials Ann O’Mara, PhD, RN, FAAN Program Director Community Clinical Oncology Program Division of Cancer Prevention June 26, 2007 NCCCP Break Out Session

2. Break Out Session Objectives Review goals for clinical trials component Review role of NPAC and your role as a network Provide clinical trials information exchange among sites, including minority & underserved accrual Provide overview of NCI clinical trials options Establish structure for NCCCP clinical trials working group & monthly calls

3. NCCCP: Clinical Trials Key Components Types of Clinical Trials –Treatment –Cancer Control and Symptom Reduction –Prevention Complexity of Trials –Phase 2 and 3 –Multimodality capacity (i.e., RT+ surgery) –Ability to do translational type trials (specimen submission-rich) Connections to the Community –Ca Ctrs, Academic Ctrs, CCOP/MBCCOPs, Coop Groups, Industry –Referrals for phase 1 –Emphasis on Minority Accrual

4. Major Activities & Metrics Year 1 Increase in number of trials open in 2 of the 3 types – obtain baseline metrics Implement patient/physician log for all screened cancer pts and high risk individuals – collect reasons why pts don’t participate in trials (reasonable to do identical survey across all 6 sites) – baseline metrics Increase in number of physicians participating in trials at each site – baseline metrics Investigation to develop new trial partnerships (CCOPs, Groups, Phase 2, etc.) – baseline metrics Investigation of new IRB processes ( regional IRB and NCI CIRB) – baseline metrics

5. Major Activities & Metrics Year 1 (cont’d) Implement or improve programs to increase minority accrual – baseline metrics Assessment of navigator’s outreach needs and their ability to accommodate expansion of program’s types of clinical trials Develop timelines for protocol receipt to activation and from IRB receipt to approval – baseline metrics Develop or improve communications in-house regarding clinical trials – baseline metrics Convene local advisory board to include community oncologic and general practitioners, lay community minority representation, related health practitioners (nursing/CRAs, radiology, pathology and surgery), advocates Perform baseline self-assessment survey on clinical trials (done uniformly across the 6 sites to permit cross-site comparisons)

6. Major Activities & Metrics Year 2 Open a phase 2, specimen acquisition-rich trial Demonstrate capacity to do multi-modality trials Design, analyze, + implement plan to increase percentage of patients going on trial – based upon patient/physician log- survey. Increase minority or underserved accrual by ? %

7. Major Activities & Metrics Year 3 Increase overall annual accrual Increase minority accrual by ? % (15%?) Increase number of open trials – in all 3 domains Improve protocol/IRB approval timelines Demonstrate quality data via an audit (by an external agency)

8. Major Activities & Metrics Year 3 (cont’d) Increase number of staff dedicated to clinical trials (physician, nursing/CRA, + pharmacy) Re-do self-assessment survey regarding clinical trials and compare to baseline – sorted by new staff and pre-existing staff

9. NCCCP: Clinical Trials Components Area Clinical Trial Component 1. Community Input Local advisory board to advise & assist pilot w/ varied membership, assist to increase awareness of importance of CTs 2. Types of Trials Types include treatment, prevention, cancer control & symptom amelioration 3. Trial Complexity Trial complexity: multimodality, phase 2, translational trials, referral to phase I ctrs 4. CT Infrastructure Infrastructure & staff dedicated to working on clinical trials, education for new staff 5. Protocol Activation Timeliness Track protocol receipt to activation, develop a log to measure timelines

10. NCCCP: Clinical Trials Components 6. Collaborations Collaborations w/ Ca Ctrs, CCOPs, Groups, Academia, Industry 7. Outreach to the Underserved Programs and outreach for minorities & underserved to participate in trials 8. Accrual Tracking Track patient accrual to trials and keep log of reasons why or why not pts go or don't go on trials 9. Communication System of communication of clinical trial availability: internal and external AreaClinical Trial Component

11. NCCCP Research Questions: Reducing Barriers to Clinical Trial Participation Ineligibility by disease, trial type, common cross-trial factors, gender, others Minority accrual issues – barriers, new research issues from the community Physician participation – reasons some docs don’t participate, don’t randomize, won’t refer CIRB utilization – if yes, how is it working? – and if no, why? Phase 2 studies – problems & solutions

12. Site Introductions Describe possible NCI-sponsored clinical trials interests your site wishes to expand (science / disease areas, etc) Describe current strategies to increase minority and underserved accrual to share with other sites