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ACRIN Research Associates Educational Session
Radiation Therapy Oncology Group Research Associates Committee
Joyce Neading, RHIT, CTRProgram Director, Cancer Research and RegistrySumma Health System HospitalsAkron, Ohio
Summa Health System, Akron,
Ohio
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
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
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
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
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
Radiation Therapy Oncology Group Organization
Group Chair
Oversight Committees Scientific Core Committees Disease Site Committees and Working Groups
Summa Health System, Akron,
Ohio
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
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
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
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
Radiation Therapy Oncology Group Research Associates Committee Organization
ChairCo-ChairSecretary
Membership Chair
Education Committee
Research Strategy
Disease Discipline
Quality Control
Poster Contest
Headquarters
Mentor Committee
Communications
Summa Health System, Akron,
Ohio
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
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
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
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
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
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
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
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
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
Any Questions?