ACRIN Research Associates Educational Session

1. ACRIN Research Associates Educational Session Radiation Therapy Oncology Group Research Associates Committee Joyce Neading, RHIT, CTR Program Director, Cancer Research and Registry Summa Health System Hospitals Akron, Ohio

2. Radiation Therapy Oncology Group History • Organized in 1968 under the direction of Dr. Simon Kramer • A national clinical cooperative group • Purpose of conducting radiation therapy research and cooperative clinical investigations • NCI funding began in 1971 • First study activated was adjuvant methotrexate study for advanced head and neck cancer enrolled over 700 patients • A milestone in multidisciplinary clinical research Summa Health System, Akron, Ohio

3. Radiation Therapy Oncology Group Objectives • Increase survival in patients with malignant diseases • Demonstrate the contributions of new modalities for treatment • Improve the quality of life of cancer patients • Prevent second and subsequent malignancies in patients cured of cancer • Seek greater understanding of the biology of cancer Summa Health System, Akron, Ohio

4. Radiation Therapy Oncology Group Membership • Full Member Institutions – 37 Active • Personnel Required: 3 full-time radiation oncologists, 1 staff radiotherapist/200-225 new patients treated per year, 1 full-time Board-certified Physicist, research staff • Equipment Required: 2 megavoltage units with at least one unit for every 300 new cancer patients treated each year with capability of obtaining field areas of 35 cm x 35 cm, diagnostic quality for localization and simulation, treatment planning system capable of generating isodose distribution • Fifty percent of patients should be considered curable • Institutional Review Board (IRB) and Federal Wide Assurance (FWA) approved by Office for Human Research Protections (OHRP) Summa Health System, Akron, Ohio

5. Radiation Therapy Oncology Group Membership • Affiliate (234 active) and CCOP (33 active) members • Personnel Required: 1 full-time radiation oncologist, 1 staff radiotherapist/200 to 225 new patient treated per year, a part-time physicist, ability to handle data management, representation of medical oncology, surgery and pathology with commitment of full-time people to participate in RTOG • Equipment Required: 1 megavoltage unit with capability of obtaining field areas of 35 cm x 35 cm, diagnostic quality for localization and simulation, treatment planning section able to plan and implement radiotherapy techniques, access to computer for treatment planning dosimetry • Minimum of 250 to 300 new patients treated per year • Institutional Review Board (IRB) and Federal Wide Assurance (FWA) approved by Office for Human Research Protections (OHRP) Summa Health System, Akron, Ohio

6. Radiation Therapy Oncology Group Annual Accrual Requirements • Full Member – 25 treatment and/or cancer control credits • Affiliate Member – 5 treatment and/or cancer control credits • CCOP – 10 treatment and/or cancer control credits Summa Health System, Akron, Ohio

7. Radiation Therapy Oncology Group Organization Summa Health System, Akron, Ohio

8. Radiation Therapy Oncology Group Committees – Oversight Committees • Data Monitoring • Patient Advocacy • CCOP Membership • Quality Control • Research Strategy • Executive • New Investigators • Research Associates * • Publications • Nominating • Steering • Membership Evaluation Summa Health System, Akron, Ohio

9. Radiation Therapy Oncology Group Committees – Scientific Core Committees • Advanced Technology Integration • Medical Physics • Pathology • Translational Research Program • Medical Oncology • Health Services Research and Outcomes • Surgical Oncology Summa Health System, Akron, Ohio

10. Radiation Therapy Oncology Group Committees – Disease Site Committees and Working Groups • Brain Tumor • Gastrointestinal Cancer • Gynecologic Cancer Working Group • Lung Cancer • Breast Cancer Working Group • Genitourinary Cancer • Head and Neck Cancer • Sarcoma Working Group Summa Health System, Akron, Ohio

11. Radiation Therapy Oncology Group Research Associates Committee • Research Associates Committee formed in 1984 • Purpose – to represent the interests of research associates in the Radiation Therapy Oncology Group • Mission – each committee of the Radiation Therapy Oncology Group will have a research associate member to represent the research associates’ perspective as well as act as a liaison between the RTOG committee and the Research Associates Committee to facilitate the conduct of studies Summa Health System, Akron, Ohio

12. Radiation Therapy Oncology Group Research Associates Committee Organization Summa Health System, Akron, Ohio

13. Radiation Therapy Oncology Group Research Associates Committees – Function • Chair presides over the Research Associates Steering Committee and the Research Associates Committee and meetings • Co-chair assists the chair with conduct of meetings, co-chair functions as chair in absence of chair • Secretary records minutes of meetings • Membership chair maintains a database of Research Associates Committee members with contact information Summa Health System, Akron, Ohio

14. Radiation Therapy Oncology Group Research Associates Committee – Function of Education Committee • Education Committee plans and develops the Research Associate Panel Discussion and Research Associates Scientific Session • Determine subject matter based on needs assessment • Recruit speakers • Apply for continuing education credits for nurses and research associates • Chair and co-chair introduce speakers and moderate program • Collect evaluation forms and distribute CE certificates Summa Health System, Akron, Ohio

15. Radiation Therapy Oncology Group Research Associates Committee – Function of Research Strategy • RA Research Strategy Committee was formed to offer research associates the opportunity and forum to conduct clinical research; be a principal investigator • Research associates develop concepts for supportive care or intervention protocols • The first RA protocol using Biafine cream in breast cancer patients receiving radiotherapy was published and presented at ASTRO in 2005 • Another protocol using Biafine cream in head and neck patients receiving radiotherapy was published in 2006 • The Committee has two concepts in development; acidophilus to reduce thrush in head and neck cancer patients receiving RT +/- chemotherapy and Linde serum for cetuximab induced rash Summa Health System, Akron, Ohio

16. Radiation Therapy Oncology Group Research Associates Committee – Function of Disease Discipline • Members of Disease Discipline are assigned to the Disease Site Committees and Working Groups to represent the concerns of the research associates at RTOG meetings • Protocols in development are reviewed by the research associate assigned to determine feasibility of the study and its conduct in RTOG institutions • Developed an Acuity Tool to determine the complexity of each trial reviewed Summa Health System, Akron, Ohio

17. Radiation Therapy Oncology Group Research Associates Committee – Function of Quality Control • A research associate sits as a member of the RTOG Quality Control Committee • Areas of deficiencies found at time of audit are discussed • The research associate member reports concerns of Quality Control regarding deficiencies to the Research Associates Committee • The member meets with the Education Committee who develop programs to educate research associates in ways to prevent deficiencies and improve data quality Summa Health System, Akron, Ohio

18. Radiation Therapy Oncology Group Research Associates Committee – Function of Poster Contest • Research associates are invited to participate in the Poster Contest held at the summer RTOG meeting • The Poster Contest Committee recruits poster presenters and coordinates the contest • Posters are displayed • Judges score the posters and determine a winner • The winner is announced at the RTOG business meeting • Winner is awarded $750 travel voucher to any educational meeting Summa Health System, Akron, Ohio

19. Radiation Therapy Oncology Group Research Associates Committee – Function of Headquarters • RTOG Headquarters assigns a member to the Research Associates Committee • Representative updates the Research Associates Committee about activities at Headquarters • Concerns and questions of research associates are taken to Headquarters by the representative member for resolution • Headquarters representative offers educational opportunities to the Education Committee and the Research Associates Committee as a whole Summa Health System, Akron, Ohio

20. Radiation Therapy Oncology Group Research Associates Committee – Function of Mentor Committee • Established by RTOG Membership Evaluation Committee • Purpose: assist any institution with Membership Evaluation scores that are unacceptable, i.e. <80% • Assist with audit preparation, cleaning up data, educating staff, help PI assess staffing levels and develop action plans • Qualifications: > 5 years experience from full member institution or affiliate institution entering 10-20 cases/year; acceptable data quality scores and site visits, approval from home institution and approval by HQ data management staff and/or audit staff Summa Health System, Akron, Ohio

21. Radiation Therapy Oncology Group Research Associates Committee – Function of Communications Committee • Communications Committee coordinates publication of the RA Reporter • Recruit writers and articles • Writes articles • Photographs events at RTOG semiannual meetings for publication in the newsletter • Work with RTOG Headquarters to publish the newsletter and post it on the RTOG webpage Summa Health System, Akron, Ohio

22. Any Questions? Summa Health System, Akron, Ohio