acrin research associate educational session

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


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


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)


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)


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


Ohio

Radiation Therapy Oncology Group Organization

Group Chair

Oversight Committees Scientific Core Committees Disease Site Committees and Working Groups


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


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


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


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


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


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


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


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


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


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


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


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


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


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


Ohio

Any Questions?

acrin research associate educational session

Health & Medicine