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NCCTG Overall Organization - Grothey

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  • Drs. Stewart and Anderson, Dr. Meeker, distinguished members of the review panel, and NCI staff: Thank you for the time and effort you have already put forward on behalf of the NCCTG grant proposal. We appreciate your willingness to serve in this capacity.
  • MCCC leadership guides NCCTG in its four overarching specific aims:
    To improve the duration and quality of life of cancer patients
    To improve the understanding of cancer biology and the biological consequences of treatment
    To improve clinical trial design and conduct
    To provide an infrastructure for studies of cancer prevention and symptom management
  • Ideas for NCCTG trials come not only from Mayo Clinic, but also from faculty members of other academic centers, community oncologists, NCI staff, other Cooperative Groups, and industry collaborators. The job of NCCTG leadership is to focus the best ideas into appropriate clinical and translational studies to be carried out in the community setting.
  • From its inception, NCCTG was organized as a partnership between community oncology practices and the Mayo Clinic Cancer Center. Our underlying assumption is that most cancer patients in the United States are treated in the community setting. Consequently, the most appropriate venue for assessing the impact of therapeutic interventions is in the community. The formal organization of the Group reflects that philosophy. Dr. Kugler, Chair of the NCCTG Executive Committee, will describe the contributions of NCCTG community membership and the Mayo Clinic Research Base.
    Good morning. My name is John Kugler. I am principal investigator of the Peoria, Illinois CCOP, and as Dr. Buckner said, Chair of the NCCTG Executive Committee. It is my pleasure to describe the role and contributions of community oncology practices and the NCCTG.
  • NCCTG began in 1977 as an outreach program of the Mayo Clinic Cancer Center with 7 members in 5 states.
  • Updated to 2008
  • Updated to 2008
  • Of these 40 members 29 are CCOP and 11 are non-CCOP members. Each membership also leads its own local network of affiliates. With the exception of the three Mayo Clinic memberships in Rochester, MN, Jacksonville, FL, and Scottsdale, AZ, and the Howard University membership in Washington, DC, all NCCTG memberships represent community oncology practices. (next slide)
  • The Executive Committee is the highest decision-making body of the NCCTG, and provides direction and oversight of the Group. The voting members of the Executive Committee include the principal investigator for each membership and the community oncology Modality Committee Co-chairs of the Medical Oncology, Pathology, Surgery, and Radiation Oncology Committees. As stated previously, I serve as the chair of the Executive Committee, and Dr. Phil Stella, principal investigator of the Ann Arbor, MI CCOP, serves as the Vice-Chair. From this organizational structure, it should be apparent that community cancer care providers have substantial responsibility for the oversight of the Group. This partnership between community oncologists and Mayo Clinic Cancer Center is a distinctive feature of NCCTG.
  • At its 2000 review, the NCCTG was encouraged to increase community member involvement in protocol development and conduct.
    Currently, community oncologists serve as co-chairs of scientific committees. In this capacity, we provide input regarding the types of problems patients in our communities experience, and types of trials that are likely to be relevant for our patients.
    We participate in protocol review, with particular emphasis on the feasibility of the trial locally. comfort level with proposed interventions, and the protocol tests that are considered to be appropriate standard of care.
    Community oncologists also serve as co-chairs of protocols. We help promote protocol accrual among the memberships, advise leadership of problems encountered in the conduct of the trials, and assist in the interpretation of results.
    Community physicians and CRAs serve on the Audit Committee and participate in every NCCTG audit, creating a learning environment that verifies and improves data quality, and provides educational opportunities for all participants.
    Finally, the NCCTG Patient Advocate Committee has organized and trained a cadre of local patient advocates to partner with community practices to promote clinical trial participation in NCCTG and other cooperative group trials.
  • In the current grant period, community membership contributed 78% of NCCTG’s total accrual to cooperative group trials.
    Every NCCTG coordinated trial in the current grant period was opened at a community site and accrued community patients.
    Since 2003, 54 audits have been conducted at our community memberships, with only a single unacceptable rating despite the NCCTG’s rigorous audit procedures.
  • These data illustrate the NCCTG organizational paradigm: community oncology programs return clinical data and biospecimens to the Research Base.
    NCCTG leadership coordinates collaboration with its multiple scientific partners.
    While this model is not unique, we believe it is very effectively incorporated into the culture of the NCCTG.
    Dr. Buckner will now further elaborate upon the role of the Mayo Clinic as the Research Base for NCCTG.
  • The Mayo Clinic Serves as the scientific and administrative Research Base for NCCTG. MCCC provides all scientific and administrative committee leaders for the Group.
  • Moreover, integration with MCCC operational and technical infrastructure provides economies of scale that permit NCCTG to operate more efficiently than if it were a stand alone organization.
  • Finally, NCCTG programs are enhanced by direct financial support provided directly by Mayo Foundation for Education and Research.
  • These aims are carried out through the efforts of 4 disease specific, 3 discipline-oriented, 3 modality, and 5 core function committees, with a foundation of support by the Statistics and Data Center, and Advisory Committees that include the Translational Research Coordinating Committee.
    Translational Research occurs in the context of three settings: within individual protocols; across protocols within disease, discipline, and modality committees; and across committees. There is a translational research liaison for each Disease and Discipline Committee that serves on the Translational Research Coordinating Committee. These individuals serve to identify scientific ideas in common with other committees, and advise each committee regarding potential opportunities for collaboration.
    Coordination and collaboration for individual projects occurs through interactions among liaisons from each of the appropriate committees.
  • At the end of 2005, NCCTG activated 61 protocols. 28 were actively accruing, 24 new trials were in development, and 103 were closed, but actively following patients. In addtion, NCCTG participated in 65 cooperative group trials led by other groups.
  • Accrual to NCCTG-led trials was 8,631 patients, with 3,952 patients entered by NCCTG members and the remainder from other cooperative groups.
    NCCTG members contributed 3,307 patients to studies coordinated by other cooperative groups.
  • NCCTG published 217 manuscripts, including numerous publications in high impact journals. There were also 18 publications in the International Journal of Radiation Oncology Biology and Physics, demonstrating the multidisciplinary nature of NCCTG research. The presentations and publications support NCCTG specific aims.
  • Updated to 2008
  • In the future, as in the past, we will begin development of improved therapeutics by identifying the most critical needs of the patient. At the present time, treatment involves multiple modalities, including surgery, radiation therapy, targeted agents and chemotherapy. NCCTG will evaluate each of these modalities individually when appropriate, but will place particular emphasis on multimodality therapy that incorporates targeted agents. In our opinion, targeted agents, in rational combinations with each other and with other treatment modalities provide tremendous promise for improving outcomes in patients with cancer. The Committee presentations that will follow provide specific examples of this approach within their respect areas of investigation.
    We also posit that not only duration of survival, but quality of life as measured by symptom improvement, treatment-related morbidity, and summative measures of quality of life are important in assessing the impact of therapeutic interventions. Goals to address these aspects of therapeutic interventions are important components of clinical trial design and conduct.
  • Translational research involves understanding both the biologic makeup of the patient as well as tumor biology. NCCTG is placing increased emphasis on pharmacogenomics. Individual genetic variations may result in differences in both efficacy and toxicity of therapeutic interventions. Dr. Araba Adjei will describe our approach to pharmacogenomics in the poster session.
    In addition, we are beginning to evaluate the intersection of pharmaceutical interventions and the human immune response. We will place greater emphasis on these interactions in the future, as described by Dr. Svetomir Markovic in the poster session.
    We have provided examples that demonstrate our strong track record in assessing tumor biology as it relates to prognostic variables, and, more recently, predictive variables. We will continue these efforts in the future, using not only paraffin embedded tissues, but also circulating tumor cells. Utilizing the NCCTG Biospecimen Resource, we have begun to explore the utility of circulating tumor cells as markers of prognosis and response to therapy. Dr. Wilma Lingle will discuss NCCTG efforts in this regard in the poster session.
  • In summary, we have demonstrated that NCCTG research has identified practice changing therapies, clinically meaningful translational results, influential methodological analyses, and a fertile environmental for cancer control research.
    We are committee to collaboration with community oncologists as well as academic medical centers.
    Finally, with direct non-capitation funding of less than $3 million dollars annually during the current grant period, including support for the Statistics and Data Center, Operations Center, Scientific and Administrative Leadership, and all Discretionary and Developmental Funds, we believe that our performance demonstrates high value for NCI’s investment in terms of productivity, quality, and efficiency.
    Thank you again for your participation in this review. I will be happy to address questions at this time.
  • Transcript

    • 1. Patient Advocacy Symposium June 9, 2008 Axel Grothey, MD Group Vice Chair
    • 2. CP1223393-2 3 Trial design and conduct • To improve clinical trial design and conduct 1 Improved therapeutics • To improve the duration and quality of life of cancer patients Specific Aims 22 Translational research • To improve the understanding of cancer biology and the biological consequences of treatment 4 Cancer prevention and control • To provide an infrastructure for studies of cancer prevention and symptom management
    • 3. CP1223393-3 Idea Generators NCCTG Programs NCCTG Leadership NCCTG Organizational Overview MCCC and other academic centers Cooperative groups Industry NCI Community Oncologists Community Oncology Programs
    • 4. CP1223393-4 Community-Based Partnership
    • 5. NCCTG in 1977 WA OR ID MT Saskatchewan WY UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY OH VA PA NY ME NHVT IA IL WI Ontario Mexico GA TX LA AR AL TN MS OK SC IN WV AK MD DE NJ CT RI MA PR HI DC
    • 6. CP1223393-6 The 43 NCCTG Memberships AreThe 43 NCCTG Memberships Are Headquartered in 28 States & CanadaHeadquartered in 28 States & Canada AK HI PR WA OR ID MT Saskatchewan WY UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY WV VA PA NY MD DE NJ CT RI MA ME NHVT IA IL WI DC GA TX LA AR AL TN MS OK SC IN OH
    • 7. CP1223393-7 NCCTG has >340 treating locations in 33NCCTG has >340 treating locations in 33 states as well as Canada & Puerto Ricostates as well as Canada & Puerto Rico (Pending/newly approved treating locations in red states) AK WA OR ID MT Saskatchewan W Y UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY OH VA PA NY MD DE NJ CT RI MA ME NHVT IA 19 12 5 6 3 IL WI DC 37 25 17 45 2 42 5 2 4 HI GA10 TX LA AR AL TN MS OK 2 2 6 1 16 SC3 IN 1 14 9 16 WV 1 PR 21 1 1 2 2 2 2 4 AK WA OR ID MT Saskatchewan W Y UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY OH VA PA NY MD DE NJ CT RI MA ME NHVT IA 19 12 5 6 3 IL WI DC 37 25 17 45 2 42 5 2 4 HI GA10 TX LA AR AL TN MS OK 2 2 6 1 16 SC3 IN 1 14 9 16 WV 1 PR 21 1 1 2 2 2 2 4 AK WA OR ID MT Saskatchewan W Y UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY OH VA PA NY MD DE NJ CT RI MA ME NHVT IA 19 12 5 6 3 IL WI DC 37 25 17 45 2 42 5 2 4 HI GA10 TX LA AR AL TN MS OK 2 2 6 1 16 SC3 IN 1 14 9 16 WV 1 PR 21 1 1 2 2 2 2 4 AK WA OR ID MT Saskatchewan WY UTNV CA AZ NM CO NE SD ND MN MOKS FL NC MI KY OH VA PA NY MD DE NJ CT RI MA ME NHVT IA 19 12 5 6 3 IL WI DC 37 25 17 45 2 42 5 2 4 HI GA10 TX LA AR AL TN MS OK 2 2 6 1 16 SC3 IN 1 14 9 16 WV 1 PR 21 1 1 2 2 2 2 4
    • 8. 8 New members since last meeting • Keith Lanier, MD – Columbia River CCOP, Portland, OR • Meera Ravidranathan, MD – New Mexico MBCCOP, Richmond, VA • Mary Helen Hackney, MD – Virginia Commonwealth MBCCOP, Richmond, VA • Marianne Lange, MD – Grand Rapids Clinical Oncology Program, Grand Rapids, MI • Jacqueline Vuky, MD – Virginia Mason Research Center CCOP, Seattle, WA
    • 9. CP1223393-9 Membership and Governance Membership • 32 CCOPs • 11 Non-CCOPs Executive Committee Membership PI and Modality Co-Chairs • Chair: J. Kugler – Peoria, IL • Vice Chair: P. Stella – Ann Arbor, MI
    • 10. CP1223393-10 Membership and Governance Membership • 32 CCOPs • 11 Non-CCOPs Executive Committee Membership PI and Modality Co-Chairs • Chair: J. Kugler – Peoria, IL • Vice Chair: P. Stella – Ann Arbor, MI
    • 11. CP1223393-11 Community Member Involvement • Co-Chairs of scientific committees • Participate in protocol review • Co-chairs of protocols • Audits • Patient Advocate Network
    • 12. CP1223393-12 Community Accrual and Data Quality • 78% of NCCTG accrual from the community • Every NCCTG coordinated trial in last grant period opened and accrued patients at a community site • Since 2003: 60 audits; 1 unacceptable
    • 13. 13 ASCO Community Participation Award Nominees 2008 Preston D. Steen, M.D. MeritCare Hospital CCOP Fargo, ND Roscoe F. Morton, M.D. Iowa Oncology Research Association CCOP Des Moines, IA
    • 14. CP1223393-14 NCCTG Organizational Overview NCCTG Leadership Idea Generators Clinical data Biospecimens MCCC and other academic centers Cooperative groups Industry NCI Community Oncologists Community Oncology Programs
    • 15. CP1223393-15 Mayo Clinic Cancer Center • Leadership • Integrated systems • Financial support
    • 16. CP1223393-16 Mayo Clinic Cancer Center • Leadership • Integrated systems • Financial support
    • 17. CP1223393-17 Mayo Clinic Cancer Center • Leadership • Integrated systems • Financial support
    • 18. NCCTG Committees Discipline-Oriented Scientific • Cancer Control • Novel Therapeutics • Quality of Life Modality • Pathology • Radiation Oncology • Surgery Core Function • Audit • Cancer Health Disparity • Oncology Nursing • Clinical Research Assoc Board • Patient Advocates Statistics and Data Center • Biostatistics Advisory • Translational Research Coord Loprinzi Martenson Jatoi Brown Goetz Erlichman Adjei Galanis Halyard Grothey Jatoi Brown Visscher Smyrk Aubry Scheithauer Halyard Martenson Schild Brown Pockaj Cima Nichols New Perotti Pearson Garces Leitch Greder Finck DeKrey Kowbell Mahacek Barnick Rogers Dillavou Smith DeLucca Keller Buckmeier Dueck Sargent Mandrekar Ballman Goetz Sinicrope Molina Jenkins Breast Gastrointestinal Lung Neuro-oncology Disease Specific LIAISONS
    • 19. CP1223393-19 Protocol Activity 2001-2005 NCCTG-led 61 • Actively accruing 28 • In development 24 • Closed, in follow up 103 NCCTG-endorsed 65
    • 20. CP1223393-20 Accrual to NCCTG Trials 2001-2005 NCCTG-led • Patients 8,631 • NCCTG member accrual 3,952 NCCTG-endorsed • NCCTG member accrual 3,307
    • 21. CP1223393-21 NCCTG Manuscripts – 2001-2006 (Published and Accepted) Total 217 • NEJM 5 • JNCI 4 • JCO 60
    • 22. CP1223393-22 Abstracts and Presentations ASCO 2001-2007 Total 229 • Plenary 2 • Oral 63 • Poster discussion 66 • Poster 80 • Publication 18
    • 23. CP1223393-23 ASCO Abstracts 2008 Oral Poster Discussion Poster Publication Pending 10 9 14 11 17 16 6 6 2 0 49 42 Numbers in red are NCCTG-Led
    • 24. 24 ASCO Abstracts 2008 Brain Breast Cancer Control GI Lung Novel Therapeutics QOL Statistical Methods Numbers in red are NCCTG-Led Studies (4 ASCO GI) 3 2 9 6 7 7 15 13 6 5 3 3 4 4 2 2 49 42
    • 25. CP1223393-25 Aim 1 Improved Therapeutics Future Plans THE PATIENT Targeted therapies Chemo- therapy Radiation Surgery Measure of Success Survival AND Quality of Life
    • 26. CP1223393-26 Aim 2 Translational Research Future Plans THE PATIENT Patient Biology Pharmaco- genomics Immunology Tumor Biology Tumor tissue biomarkers
    • 27. CP1223393-27 NCCTG High-quality science • Practice-changing therapies • Clinically meaningful translational results • Influential methodologic analyses • Active cancer control research Committed to collaboration • Community oncology and academic centers

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