Cooperative Group /JCOG. Multi-modality therapy. Cooperative Group. adjuvant therapy. Chemoradiation % % 7.5% 7.2% 7.0% 2.5% 2.1% 19.

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1 Cooperative Group 5. /JCOG 1. Multi-modality therapy Cooperative Group 5. adjuvant therapy Chemoradiation 2000 : , 2.5% 2.1% 3.1% 3.2% 4.2% 4.3% 6.4% 6.8% 6.9% % 8.3% 8.0% 7.7% 7.5% 7.2% 7.0% /22.4% % % 3.6% 3.7% 3.8% 3.9% 4.6% 5.8% % % % % 8.5%

2 2001 / % 7.3% 32.4% 33.4% Registration trial IND (Investigational New Drug) trial Industry-sponsored trial Investigator-initiated trial RCT 1 / /

3 NCIC MRC 1950 EORTC SWOG CALGB ECOG 1962 NSABP NCCTG RTOG GOG COG ACOSOG Cooperative Group WJTOG JFMC NSAS JCOG Cooperative Group 5. 60% Cooperative Group ASCO plenary session 6 Cooperative Group Patient-reported outcome: PRO / 4. Cooperative Group 5. / etc. central, site-visit 3. Phase I Phase II Phase III true surrogate Phase II Phase III Benefit Phase II / Risk / Quality of Life QOL MTDDLT Endpoint surrogate endpoint true endpoint /stage / HbA1c rationale

4 sample size JCOG9511 Scandinavian Simvastatin Survival Study (4S) or 70 Lancet 344, N Engl J Med CASE-J Candesartan Antihypertensive Survival Evaluation in Japan 23 (1) mmHg70y:160mmHgor 90mmHg 1 180mmHg or 110mmHg II FBS126mg/dl, BS200mg/dl,, TIA or Cr1.3mg/dl II vs. TIA etc. 40% 3200 ACE Ca FDA Cooperative Group etc vs. 5. A B 3 Essential Components / Data & Safety Monitoring Investigators Data Coordinating Center Data coordinating center Treatment coordinating center Central Labo. Reading Center ECG

5 Cooperative Group Statistical/Data Center MD Operations Office/Center MD Data & Safety Monitoring 1 10 Central Labo MD Protocol Review Group Chair RCT streptomycin vs RCT NCI - Dr. Gordon Zubrod RCT 6-mercaptopurine, methotrexate Acute Leukemia Group A, B 1976 Cancer and Leukemia Group B CALGB Zubrod Eastern Solid Tumor Group 1956 RCT Eastern Cooperative Oncology GroupECOG Southwest Cancer Chemotherapy Study Group (SWCCSG) 1973 The Southwest Oncology GroupSWOG 1955 NCI Clinical Studies Panel 1958 RCT Cooperative groups Clinical Trials Cooperative Group Program NCI 500$ $ NCI-sponsored Cooperative Groups NCI DHHS Department of Health & Human Services OHRP Office for Human Research Protection Adult, multi-modality ( Big 4 ) ACF AOA AHCPR CDC FDA HCFA HRSA IHS PSC SAMHSA NIH Health Care Cancer and Leukemia Group B (CALGB) Food & Drug Financing National Institute Administration Administration of Health Clinical center Eastern Cooperative Oncology Group (ECOG) NEI NHLBI NHGRI NIA NIAAA NIAID NNIAMS NICHD NIDCD NIDCRNIDDKD NIDA NIEHS North Central Cancer Treatment Group (NCCTG) NIGMS NIMHNINDSNINR NLM NCI CC CIT NCCAM NCRR FIC CSR National Cancer Institute Southwest Oncology Group (SWOG) 4000 full time2000 NCI-Frederick IND Disease-oriented DCTD Division of Cancer Treatment and Diagnosis DCP Division of National Surgical Adjuvant Breast and Bowel Project DTP CTEP CTC(AE) Cancer Prevention Cancer Therapy (NSABP) Discovery, screening, Evaluation Program manufacturing Research Bases Gynecologic Oncology Group (GOG) CCOP: 50 Community Clinical Specific types SWOG NSABP ECOG Oncology Program Univ. Jonsson Wisconsin Kimmel Kaplan Yale Univ. Fred Hutchinson Duke Univ. RTOG CALGB GOG American College of Surgeons Oncology Group (ACOSOG) Roswell Park Dana-Farber MD Anderson Radiation Therapy Oncology Group (RTOG) Fox Chase Johns Hopkins Epply NCCTG COG ACOSOG CRC NCI-sponsored NCI-sponsored Community Children s Oncology Group (COG) Cancer Center : 60 Cooperative Group : 9 Hospitals translational - phase I - phase II phase II - III, prevention /Oncologists

6 1 NCI NCI Clinical Trials Cooperative Group Program / Cancer Center Program 1963 P30 Cancer Center Support Grant FDA IND application phase Iphase II NCI 2 /1 3 phase III Taxol CRC 3. Cooperative groups NCI-CTEP Community Clinical Oncology ProgramCCOP 1983 NCI 50 CCOPs 13 Minority CCOP CRC NCI-CTEP 3 Cooperative groups Community hospitals NCI-DCP CCOPCommunity Clinical Oncology Program Cooperative Group phase II phase III Multi-modality Group NIH FDA / Disease-specific Group Multi-disease Group JCOG vs 2000 Cancer Cooperative Groups WJTOG ( ) -NPO - JMTO (multi-disease) -NPO NSAS/CSPOR ( ) JFMC (multi-disease) - - Cooperative Group JCOG (multi-disease) NPO - QA + QC Cooperative Group Sponsor investigator ICH-GCP sponsor-investigator

7 Cooperative Group SWOG ? Phase III HQ 85 Multi-disease group EORTC JCOG Disease-oriented NSABP NSAS ? Cooperative Group NPO or multi-disease group CRFCase Report Form Phase II phase III Phase Iphase I/II Cancer Centers EORTC sponsor Cooperative group NCI FDA NCI Multi-disease vs. Disease-specific Cooperative Group Multi-disease Disease-specific Cooperative Group Group Group / Pros. peer review Cooperative Group Cons. NSABPSWOG SWOGNSABP JCOG Cooperative Group Cooperative Group Cooperative Group CRCDMSoCRA CTC(AE) / RECIST Pros Cons Cooperative Group Case Report Form QA NCI

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