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Accrual Targets Ethnic Category Sex/Gender Females Males Total Hispanic or Latino + = Not Hispanic or Latino + = Ethnic Category: Total of all subjects (A1) + (B1) = (C Racial Category American Indian or Alaskan Native + = Asian + = Black or African American + = Native Hawaiian or other Pacific Islander + = White + = Racial Category: Total of all subjects (A2) + (B2) = (C (A1 = A2) (B1 = B2) (C1 = C2) Accrual Rate: pts/month Total Expected Accrual: Min Max Projected Start Date of Study: HHS Racial and Ethnic Categories I. American Indian or Alaskan Native: A person having origins in any of the original peoples of North America, and who maintains cultural identification through tribal affiliation or community recognition. II. Asian or Pacific Islander: A person having origins in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent, or the Pacific Islands. This area includes China, India, Japan, Korea, the Philippine Islands, and Samoa. III. Black, not of Hispanic Origin: A person having origins in any of the black racial groups of Africa. IV. Hispanic: A person of Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish culture or origin, regardless of race. V. White, not of Hispanic Origin: A person having origins in any of the original peoples of Europe, North Africa, or the Middle East. Special Populations: Individuals from special populations (minorities, cancer survivors, HIV+ individuals, pregnant and breast-feeding women) can NOT be arbitrarily excluded from participation on a study. All exclusions must be justified based on establishment that inclusion is inappropriate with respect to the health of the research subjects or the purpose of the research. 6.4 Coordination of Planning with the Clinical Investigations Branch (CIB), CTEP The Clinical Investigations Branch (CIB) of CTEP is responsible for scientific oversight and coordination of large, multicenter clinical trials exploring innovative disease therapeutics and biomarkers. CIB partners with public and private entities to expand Section 6 - Investigator’s Manual 2009 28
clinical trial participation to all populations. Large clinical trials involve years of effort and a substantial expenditure of resources. Accordingly, a certain amount of coordination is necessary for the optimal planning of specific studies of this type. CIB staffs are well positioned to advise investigators about the existence of other proposed or ongoing studies that are closely related or even identical to studies being planned. In addition, CIB staff can advise investigators contemplating large-scale trials concerning the proposed trial’s concordance with CTEP program goals. CIB staff can evaluate investigators’ ideas for clinical trials before they invest time and energy to develop a complete protocol. Although investigators proposing phase 1 and phase 2 studies using CTEP resources are required to submit a Letter of Intent (LOI), for phase 3 studies, CTEP requires investigators to submit a written Concept using a phase 3 Concept Submission Form (http://ctep.cancer.gov/forms/docs/concept_submission.doc). The NCI disease-specific Steering Committee overseeing that disease area and/or CTEP must evaluate Concepts for phase 3 studies. In general, these provide a description of the proposed study, including the hypothesis to be investigated, its rationale, and relevant design considerations. CTEP can then formally review and provide a written Program Concept Review commenting on study originality and programmatic interest. 6.5 Cancer Trials Support Unit (CTSU) In response to the Armitage Report, a 1997 report from the NCI’s Clinical Trials Program Review Group, the Cancer Trials Support Unit (CTSU) was established to: (1) facilitate physician and patient access to NCI-sponsored clinical trials through an efficient enrollment procedure that helps cross-Group accrual and permits non-Group members to enroll patients on NCI-sponsored trials; (2) streamline data entry and collection for clinical trials using standard case report forms and reporting; and (3) reduce regulatory and administrative burdens on clinical trials by unifying and standardizing Group membership rosters and institutional review board (IRB) approvals. The CTSU includes all clinical trials Cooperative Groups that study cancer treatments and allows the members of any Cooperative Group to participate in any phase 3 trial (or selected phase 2 trial) led by a Cooperative Group that is available on the CTSU clinical trials menu. In general, all Cooperative Group phase 3 trials are available on the CTSU menu. In addition, the CTSU has other initiatives. These include • the CTSU Independent Clinical Research Site (CICRS) Program which allows some investigators/institutions that do not belong to a Cooperative Group to participate in Group trials • the Clinical Research Network (CRN) which is a pilot program supporting trials for other NCI-sponsored clinical trials networks. Additional information on the CTSU can be found on its web site at https://www.ctsu.org/. Section 6 - Investigator’s Manual 2009 29
Page 1 and 2: A Manual for Clinical Investigators
Page 3 and 4: 7.1.3 Purpose .....................
Page 5 and 6: 13.4 Responsibilities of Clinical S
Page 7 and 8: 1 Introduction This manual explains
Page 9 and 10: drugs and biologics rests with the
Page 11 and 12: costs might include additional labo
Page 13 and 14: 3 The Clinical Trial Site and the I
Page 15 and 16: CTEP's site visit monitoring progra
Page 17 and 18: 4 Phase 1 Trials The Development of
Page 19 and 20: Because the correlation between sch
Page 21 and 22: for organ dysfunction studies. The
Page 23 and 24: efore writing a formal LOI. IDB sta
Page 25 and 26: CTEP has based its guidelines conce
Page 27 and 28: 5.1.4 Randomized Phase 2 Studies A
Page 29 and 30: • Physician members of CCOPs for
Page 31 and 32: 6 Phase 3 Trials 6.1 Scientific Pol
Page 33: completed by the Cooperative Group
Page 37 and 38: proposer that the submission will n
Page 39 and 40: at the FDA, and for the listing of
Page 41 and 42: expected adverse events that the pa
Page 43 and 44: • How dose modifications will be
Page 45 and 46: consent forms. However, the informe
Page 47 and 48: Investigators’ failure to submit
Page 49 and 50: espond to this re-review in the sam
Page 51 and 52: 9 Ordering Investigational Agents f
Page 53 and 54: the local oncologist(s) must regist
Page 55 and 56: phase 1 include the first time the
Page 57 and 58: investigator send an additional cop
Page 59 and 60: • Altering existing research by m
Page 61 and 62: CTEP has devised a detailed policy
Page 63 and 64: 13 Affiliate Investigators The part
Page 65 and 66: 13.4.3 Cancer Centers The Cancer Ce
Page 67 and 68: 14.3 Administration of Investigatio
Page 69 and 70: • Agents are stored in various pl
Page 71 and 72: 16 Monitoring and Quality Assurance
Page 73 and 74: 16.5 Components of the Quality Assu
Page 75 and 76: Also, please note that medical reco
Page 77 and 78: • Even if the agent has been repo
Page 79 and 80: Appendix I NCI-Cooperative Group-In
Page 81 and 82: Phase 0 trials do not replace phase
Page 83 and 84: phase 2 trials enroll 20-30 patient
Page 85 and 86:
the study should be ordered under t
Page 87 and 88:
Appendix IV Key Contact Information
Page 89 and 90:
Appendix V Informed Consent Checkli
Page 91 and 92:
2. Describe risks as outlined in th
Page 93 and 94:
CLINICAL SITE: An institution, coop
Page 95 and 96:
RAB: Regulatory Affairs Branch, htt
Page 97 and 98:
• Agent preparations must be perf
Page 99 and 100:
Procedure for Acute Exposure or Spi
Page 101 and 102:
Appendix VIII National Cancer Insti
Page 103 and 104:
7) Investigational Drug Accountabil
Page 105 and 106:
• Write treatment instructions cl
Page 107 and 108:
• For agent admixtures that can b
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