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Disclosures No conflicts to disclose

Cancer Center Clinical Trials Budgeting, Resources and Prioritization George Weiner Director, Holden Comprehensive Cancer Center University of Iowa. Disclosures No conflicts to disclose.

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Disclosures No conflicts to disclose

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  1. Cancer Center Clinical TrialsBudgeting, Resources and PrioritizationGeorge WeinerDirector, Holden Comprehensive Cancer CenterUniversity of Iowa

  2. DisclosuresNo conflicts to disclose

  3. NCI designated cancer centers have developed rigorous, comprehensive approaches to clinical cancer trial scientific review, prioritization, budgeting, support, safety monitoring and accrual monitoring.  How are such activities organized at NCI designated cancer centers? (Iowa as example) How can cancer centers and CTSAs work together more efficiently in the oversight and support of clinical research?

  4. When you have seen one cancer center, you have seen one cancer center • Cancer centers vary with respect to • Free standing vs matrix • Single site vs consortium • Large vs small • Clinical vs comprehensive • Research organized based on scientific vs clinical disciplines • State, institutional, philanthropic resources

  5. Scientific input of investigator Reimbursement Academic value = Financial value Supporting Clinical Cancer ResearchThe Challenge Investigator Initiated Trial Cooperative Group Trial Industry Initiated Trial

  6. Data and Safety Monitoring Regulatory Assistance Protocol Development Protocol Management Clinical Trials Support Data Management Protocol Review Protected Time Recruitment Budgeting Training People Protocol Trial Cancer Center Investment in Clinical Cancer Trials

  7. People • Faculty • Endowments for key faculty recruits • Start-up packages • Percent effort support for key clinical investigators • Clinical trials staff • Hire broad variety of staff to support all aspects of clinical cancer research • Provide professional enrichment funds for clinical trials staff continuing education

  8. Protocols Assistance • Protocol writer and editor • Overall protocol organization and structure • Clinical trial templates • Biostatistics • Data and safety monitoring • Major educational role • Establishing budgets and financial feasibility • Routing of protocols to Cancer Center PRMC, IRB, Radiation Safety, CTSA oversight committees, etc Oversight • Cancer-type specific Multidisciplinary Oncology Group • Protocol review committee

  9. Clinical Trial • Data management • Clinical research staff dedicated to specific programs or investigators • Most hired through CC, some through Depts • Clinical research staff available for individual projects • Clinical trials support • Administrative management of ongoing trials • Budgeting and billing • Regulatory assistance • Data and safety monitoring

  10. Support for Clinical ResearchDecision Points • Recruitment and support of new investigators • Start up and % effort • Supplementation of Cooperative Group Research • % effort for staff • Early phase clinical trials without peer-reviewed support • Funds available for data management and some correlative studies from CCSG protocol specific research, philanthropy, institutional sources • Potential for leading to peer-reviewed support is major criteria in selecting which studies will receive support

  11. Support for Clinical ResearchDecision Makers Collaborative – discussed by CC executive committee Listed below is the primary individual responsible for making recommendations • Recruitment and support of new investigators • CC Director • Supplementation of Cooperative Group Research • Director, Clinical Trials Support Core • Early phase clinical trials without peer-reviewed support • Associate Director for Clinical Research based on PRMC recommendation

  12. Financial support for unfunded or underfunded clinical trials Investigator concept Discussed and Approved by Multidisciplinary Oncology Group Approved and Prioritized by Protocol Review and Monitoring Committee Support requested from Associate Director for Clinical Research Proposal submitted to Research Review Committee for seed grant support

  13. Holden Comprehensive Cancer Center Support for Clinical Cancer Research(excludes industry support and charge-back to peer reviewed funding*) • Recruitment and support of % effort for clinical investigators • Approximately $500,000/yr • Protocol development and review • Approximately $200,000/yr • Clinical trial support (non-physician staff) • Approximately $500,000/yr * In our matrix setting, grant support and industry contracts are often managed by Departments. For these, the CC focuses on reimbursement of expenses.

  14. Prioritizing Clinical Trials • Investigator initiated trials • Supported by peer-reviewed funding • Supported by other sources • High priority studies without other sources of support studies recommended by the Multidisciplinary Oncology Groups and highly rated by the PRMC • Cooperative group trials • Industry initiated trials Multicenter trials – Expectation that a minimum of 3 subjects per year will be enrolled (exceptions made for high priority trials in rare cancers)

  15. Closing Trials • Cancer Center has authority to close trials for • Poor accrual (Protocol Review and Monitoring Committee) • Safety issues (Data and Safety Monitoring Committee) • Poor accrual • PRMC sends letter to PI if • Institutional trial accrues less than 1/3 of goal in 1 year • Multi-institutional trial has no accruals over 1 year • Response • PI provides acceptable explanation for slow accrual (e.g. access to agent) • PI electively closes trial • To date, PRMC has not had to close trial against will of PI

  16. Process Improvement Event (Kaizen) • Initiated effort in late 2009 based on my involvement in OEWG • Led by trained “process engineer” – 6 sessions • Initial focus – Protocol development and review • Participants • CC (protocol development, clinical trials support, budget offices), CTSA, IRB, University Contracting, Sponsored Programs • Changes implemented • Increase frequency of PRMC meetings to 2 per month • Application forms provided to reviewers electronically • Incentive plan developed to broaden reviewer participation (professional development funds) • Streamlined other aspects of interactions between PRMC and IRB • Improved tracking of status of protocols • Benefits of networking, particularly with contracting office • Impact of process on efficiency – TBD • Current effort – Efficiency of clinical trials support

  17. Joint efforts of CCC and CTSA at Iowa • Ongoing • Approximately 30% of studies in the CTSA Clinical Research Unit are cancer-related • CTSA provides support for clinical cancer investigators in training • CTSA and CCC collaborate on training efforts and continuing education for clinical research coordinators • In development • Collaborative approach to obtaining consent, procuring and distributing biospecimens linked to de-identified clinical data • “Super-application” to streamline regulatory burden for investigators • Community outreach activities and CER

  18. $ $ Enhancing efficiency by collaborating CTSA Cancer Center People Protocol Trial Correlative Studies

  19. Conclusions • Cancer centers have established extensive infrastructure to support clinical cancer research • Disconnect between scientific and financial value of clinical research oppporunties requires thoughtful, balanced management of prioritization policies • There is great potential to increase efficiency of clinical research and provide new services to clinical investigators by identifying areas of overlap and synergy between CTSAs and Cancer Centers

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