11 Radiation Therapy Oncology Group Clinical Trials Administration Sharon Hartson Stine, Director Group Administrator

22 Historic Perspective 1967RTOG was organized under the auspices of the Committee for Radiation Therapy Studies at NCI 1968NCI awarded a grant to Jefferson Medical College to develop a cooperative group to answer radiation therapy and combined modality question, Dr. Simon Kramer was the PI RTOG was fully constituted and developed studies in several disease sites ACR became the grantee for the RTOG cooperative agreement.

33 RTOG Family Tree Department of Health and Human Services (DHHS)Department of Health and Human Services (DHHS) National Institutes of Health (NIH) National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) –Cancer Therapy Evaluation Program (CTEP) Division of Cancer Prevention (DCP) –Community Clinical Oncology Program (CCOP)

44 Funding Sources RTOG HQ & Stat Center$ 10.1 M CCOP Research Base$ 3.8 M Biospecimen Resource $ 0.8 M Pennsylvania Dept of Health$ 0.7 M Corporate Support$ 3.4 M Other$ 1.5 M Grants are awarded to the American College of Radiology on behalf of RTOG

55 Clinical Trials Administration Grant & Financial AdministrationGrant & Financial Administration Group Membership ActivitiesGroup Membership Activities –New Applications –Roster Updates –Linking to RTOG in RSS –RTOG Passwords Case ReimbursementCase Reimbursement Semiannual Meeting CoordinationSemiannual Meeting Coordination RTOG Publications ManagementRTOG Publications Management Secondary Analysis & Requests for Study DataSecondary Analysis & Requests for Study Data Requests to Use RTOG Biospecimen Resource MaterialsRequests to Use RTOG Biospecimen Resource Materials

66 RTOG Members Over 300 academic and community-based facilities in the United States, Canada and internationally participate in RTOG clinical trials, including nearly 90% of all NCI- designated comprehensive and clinical cancer centers.

77 RTOG Members 342Member Institutions342Member Institutions 36 Full Members36 Full Members 269 Affiliate Members269 Affiliate Members 35 CCOP Members35 CCOP Members 3 Provisional Members3 Provisional Members

88 Membership Requirements Full Members – 25 case credits per yearFull Members – 25 case credits per year Affiliate Members – 5 case credits per yearAffiliate Members – 5 case credits per year CCOP Members – 10 case credits per year (5 must be CCOP Credits)CCOP Members – 10 case credits per year (5 must be CCOP Credits) Data Quality & Timeliness RequirementsData Quality & Timeliness Requirements –Data Quality (no requests for additional info) – 90% –Data Timeliness: Submitted within 90 Days – 80% –Data Timeliness: Submitted within 180 Days – 85% Patient Eligibility – 90%Patient Eligibility – 90% Satisfactory AuditSatisfactory Audit

99 Evaluation Process Evaluations are done in JanuaryEvaluations are done in January Based on the previous calendar yearBased on the previous calendar year Case Accrual, Data Quality, Data Timeliness, and Audit Results are the key components of the evaluationCase Accrual, Data Quality, Data Timeliness, and Audit Results are the key components of the evaluation

10 Case Reimbursement Current Reimbursement Amounts $2,000 for treatment studies$2,000 for treatment studies $2,000 for cancer prevention & symptom management studies$2,000 for cancer prevention & symptom management studies Additional corporate support for some studiesAdditional corporate support for some studies $50 per Follow-Up Form$50 per Follow-Up Form Biospecimens (tissue, blood, urine, etc.) - Reimbursement depends on type of material, $50 - $300.Biospecimens (tissue, blood, urine, etc.) - Reimbursement depends on type of material, $50 - $300.

11 Case Reimbursement Payments for Case Reimbursement - MonthlyPayments for Case Reimbursement - Monthly Case Payment is based on:Case Payment is based on: –Submission of Key Form(s) –Case Eligibility Payments are made to the institutionPayments are made to the institution Follow-Up Payments – QuarterlyFollow-Up Payments – Quarterly Pathology – Semiannual – moving to monthlyPathology – Semiannual – moving to monthly

12 Reimbursement & Credits List Available on RTOG Web site under the “Members” tabAvailable on RTOG Web site under the “Members” tab

13 New Payment Initiatives Phase III Capitation Increases- additional $3000Phase III Capitation Increases- additional $3000 Phase II Capitation Increases- $5000 for treatment armPhase II Capitation Increases- $5000 for treatment arm New Tissue Reimbursement RatesNew Tissue Reimbursement Rates CTSU Ancillary Payment MechanismsCTSU Ancillary Payment Mechanisms Staged Case PaymentsStaged Case Payments