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Affiliate Networks Comprehensive Cancer Center Perspective Michael Benedict, PharmD Vice President, Research Moffitt Cancer Center Today Brief overview of Moffitt History with Affiliates Successes and Challenges Total Cancer Care Initiative Partnering with NCCCP sites External Research Sites : 2010 Cancer Centers of Florida Mayo Clinic, Jacksonville Ocala Oncology Univ. of Florida - Gainesville Bethesda Memorial Hosp. Project Type Broward General Med. Ctr. North Broward Med. Ctr. Martin Memorial Hospital Ponce School of Med. FIQCC CCC&R/Watson Clinic Tallahassee Memorial Space Coast Med. Assoc. Southeast Nebraska Cancer Ctr. MCC Non Intervention Sarasota Memorial Hospital MCC Clinical Intervention Baptist Hospital of Miami MCC Prevention Carolinas Medical Center Cooperative Group Our Lady of the Lake St. Vincents of Indiana Louisiana State Univ. Univ. of FL - Jacksonville Medical Univ. of SC National Cancer Institute Emory University Univ. of North Carolina Vanderbilt University SEP2C Greenville Hospital System Hartford Hospital Cleveland Clinic Fox Chase Cancer Center Billings Cancer Center Boca Raton Com. Hosp. Klinik Lowenstein, Germany Minneapolis VA Florida GYN Oncology St. Joseph’s Hospital - Tampa Jefferson Medical College Overton Brooks VA Leesburg Regional Med. Ctr. Morton Plant Mease James A. Haley VA Johns Hopkins Univ. St. Joe’s Candler, Savannah Women’s Cancer Assoc. Duke University Virginia Commonwealth Univ. Univ. of Maryland Univ. of Chicago Total Cancer Care Cornell University Montefiore Medical Ctr. Univ. of Louisville The Situation Only 2-4% of adult cancer patients enrolled in clinical trials Klabunde CN etal JNCI 2011 85% of cancer patients are treated in their local community Lack of practice standards and quality measurements Patient centered outcomes research requires community participation Access to clinical trials, esp. underserved populations is a challenge Molecularly directed medicine requires new approaches, infrastructure, and connections Benefits Expands treatment options for the patient in the community Patients can be treated close to home decreasing costs of travel and time Collaboration of institutions may increase referrals for both institutions Increase market advantage for community Barriers Cost - inadequate funding Lack of interesting trials Trial characteristics that may be difficult to implement in community Extra-biopsy Advanced Imaging Increased regulatory burden IRB availability or funding Monitoring and oversight Moffitt History with Affiliates Program began in 1998 Part of Moffitt State Mandate Instrumentality of the State Designate “Partner Hospitals” Export trials Educational opportunities, use of name/logo: Branding Referrals, marketing advantage Focus cooperative group trials Moffitt Clinical Research Network - 2006 Office created to provide oversight and centralization Protocol review and preparation Site approval/credentialing Liaison between Moffitt & site staff Regulatory, contracting, budget, payment Assisted with data entry & monitoring Training resource Moffitt Clinical Research Network Re-invigoration of the program Identified physician champion Concerted effort to place Investigator Initiated Trials (IIT) in the community Lot of Interest Limited success Accrual inconsistent Funding poor Complicated, difficult to implement Emergence of academic affiliations Project Sunshine N01 – Southeast Phase II Consortium Total Cancer Care Consortium – M2Gen Personalized Approach to a Patient’s Cancer Journey Survivorship – – – – Populations at Risk Behavioral Research Psychosocial & Palliative Care Family Needs Health Outcomes – – – – Relapsed Disease Intervention – Recurrence Therapy – Drug Discovery – Adaptive Trial Design – Prevention – Lifestyle/Nutrition – Education Diagnosis Treatment – Primary Therapy • Multimodality • Target Based – Post Therapy • Surveillance – Clinical Trials Matching – Genomics/Proteomics – Imaging Modalities – Nanotechnology Prognosis – Molecular Oncology – Biomarker Analysis (http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243) Risk Factors Genetics Early Detection Health Disparities The Purpose Identify the needs of individual patients; Identify markers that would predict needs and risks so that interventions could become preemptive; Identify molecular signatures for patients who are not likely to respond to standard of care; Utilize clinical characteristics and molecular profiling techniques to match the right patient to the right treatment at the right time the first time; Raise the standard of care for all patients by integrating new technologies in an evidenced based approach to maximize benefits and reduce costs. The Approach for Cancer Total Cancer Care Protocol Can we follow you throughout your lifetime? Can we study your tumor using molecular technology? Can we recontact you? Unique Consenting Approach Electronic Consenting System Wireless touch- screen tablet Consists of IRB Approved: Introductory Video Connects via secure interface and forwards HIPAA-compliant information to database Consent Video by PI Informed Consent Signature Capture Demographics Survey Partners in the Fight Against Cancer Billings Clinic Lehigh Valley Norton Cancer Institute, Louisville, KY Total Cancer Care Research Protocol TCC protocol active at 18 sites with over 69,871 (1) patients consented Enrolling approx 500 patients/week 9 sites in Florida and 9 sites in other states (NC, SC, NE, LA, IN, KY, CT, MI, GA) Tissue biorepository continues to expand with 22,748 (1) tissue samples collected 16,223 (1) tumors profiled Longitudinal data collection (1) As of 2/4/11 Productivity TCC Consortium sites led to interests in capitalizing on this network CCSG Administrative Supplement Intended to build linkages w NCCCP sites To better attain collaborative goals in relation to accrual to trials collection of quality biospecimens outreach to underserved populations Leverage the resources of both initiatives (CCSG – NCCCP) Due June 2009 CCSG Administrative Supplement Awarded September 2009 Partners Billings Clinic Hartford Hospital Aims Dissemination novel trials – N01 Participation in behavioral and outcomes research Capitalize on the Biospecimen processes NCCCP in Clinical Trial Participation Hartford (3 trials) Phase 2 trial in ovarian cancer Multi-arm Phase 2 trial in OC, endometrial, HCC, islet cell and carcinoid tumors Phase 1/2 trial in breast cancer Billings (5 trials) Phase 2 trial in SCC of H&N Multi-arm Phase 2 trial in OC, endometrial, HCC, islet cell and carcinoid tumors Phase 1/2 trial in breast cancer Phase 2 trial in myeloma Phase 1/2 trial of 1-MT/docetaxel in solid tumors (NCI CM-62208 N01 Contract: Southeast Phase 2 Consortium) Clinical Trials Video Evaluation Internally developed DVD about trials English and Spanish (trans-created) Send to new patients Help to initiate the Dialog about trials Prior to roll out - validation Health Outcomes and Behavior Program Paul Jacobsen, PhD NCCCP partner participation Completed - Data under review currently NCCCP Partnering Lessons Learned Eagerness to participate in research Desire a seat at the table in designing and conducting research Sophisticated infrastructure in place which is required to support trials Focused Hub of trial support ● (Clinical Trials Office) Centralize Infusion Critical mass of existing research NCCCP Partnering Lessons Learned Robust Health Information Management systems and willing to invest to linkages Community practices have unique challenges in conducting Total Cancer Care Protocol Surgical – Medical Oncology Links Integrating protocol into high volume clinical operations BUT it can be done and DONE WELL One of the best partners to help us realize personalized cancer care (molecularly directed) What’s Next Trial Matching TCC Data 3 NCCCP sites and 2 FL based consortuim members Identifying trial ready populations ● Breast ● Ovarian ● Lung What's Next Capitalize on TCC Network Patient Data Molecular Information New Type of Trial Streamlining Clinical Trials Traditional Clinical Trials ~Half the patients <Half the time >Response rates Broad Patient Population “TurboTrial” Molecularly Defined Population 10-12 Years 3-5 Years Thank you