A Manual for Participants in Clinical Trials of Investigational Agents ...

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18 Appendices Appendix I .............................................................................................................................73 NCI-Cooperative Group-Industry Relationship Guidelines Appendix II ............................................................................................................................74 Phase 0 Studies Appendix III ...........................................................................................................................76 Policy Statement: The Conduct of Phase 1 and 2 Trials in Children Appendix IV...........................................................................................................................81 Key Contact Information Appendix V............................................................................................................................83 Informed Consent Checklist Appendix VI...........................................................................................................................86 CTEP Glossary Appendix VII..........................................................................................................................90 National Study Commission on Cytotoxic Exposure: Recommendations for Handling Cytotoxic Agents Appendix VIII.........................................................................................................................95 National Cancer Institute Procedure of Investigational Agents Acquired for Compassionate (Special Exception) Treatment of Individual Patients Appendix IX...........................................................................................................................98 Guidelines for Treatment Regimen Expression and Nomenclature Table of Contents - Investigator’s Manual 2009 vi
1 Introduction This manual explains the policies and implementing procedures for the conduct of therapeutic clinical trials sponsored by the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI). Sponsorship or support of clinical trials includes funding, regulatory support and/or agent distribution. Oncologists, nurses, pharmacists, research administrators, and data managers should find the information in this manual useful in practical matters connected with protocol drafting and submissions, reporting requirements, agent accountability, and a host of other subjects. The Cancer Therapy Evaluation Program (CTEP) of the DCTD (http://dctd.cancer.gov) is responsible for implementing and monitoring the clinical development of new anticancer agents. CTEP’s policies are intended to ensure patient safety while providing the National Cancer Program with the most effective new agent development program possible. Some policies reflect the regulatory requirements of the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS). Others have been developed based on policies at the Institute level, consensus among CTEP staff, the NCI Board of Scientific Advisors, and leaders in the community of clinical investigators. Specific policies and procedures continue to evolve; through them CTEP, DCTD, NCI aims to provide a flexible, responsive system within the constraints imposed by regulation and the program’s size and scope. In addition to the scientific and medical issues involved in planning and conducting clinical research, CTEP has two additional major responsibilities: (1) Sponsorship of Investigational New Drug Applications (INDs) and (2) Oversight of the contracts, grants and cooperative agreements under which most clinical testing takes place. In this manual we refer to DCTD as the IND sponsor and the "proprietor" of the investigational agent development program and to CTEP where the efforts of the CTEP staff are specifically involved. The use of NCI is reserved for more general contexts, including overall support of clinical trials. The CTEP web site (http://ctep.cancer.gov) is an excellent additional resource for current information on CTEP policies, forms/templates and initiatives. Familiarity with CTEP’s organization and the primary responsibilities of each branch or office may help you understand how CTEP functions. We welcome readers’ comments on this manual’s content and how future updates can make this manual more useful. Section 1 - Investigator’s Manual 2009 1
Page 1 and 2: A Manual for Clinical Investigators
Page 3 and 4: 7.1.3 Purpose .....................
Page 5: 13.4 Responsibilities of Clinical S
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 and 34: completed by the Cooperative Group
Page 35 and 36: clinical trial participation to all
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
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investigator send an additional cop
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• Altering existing research by m
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CTEP has devised a detailed policy
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13 Affiliate Investigators The part
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13.4.3 Cancer Centers The Cancer Ce
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14.3 Administration of Investigatio
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• Agents are stored in various pl
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16 Monitoring and Quality Assurance
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16.5 Components of the Quality Assu
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Also, please note that medical reco
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• Even if the agent has been repo
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Appendix I NCI-Cooperative Group-In
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Phase 0 trials do not replace phase
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phase 2 trials enroll 20-30 patient
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the study should be ordered under t
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Appendix IV Key Contact Information
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Appendix V Informed Consent Checkli
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2. Describe risks as outlined in th
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CLINICAL SITE: An institution, coop
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RAB: Regulatory Affairs Branch, htt
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• Agent preparations must be perf
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Procedure for Acute Exposure or Spi
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Appendix VIII National Cancer Insti
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7) Investigational Drug Accountabil
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• Write treatment instructions cl
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• For agent admixtures that can b
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A Manual for Participants in Clinical Trials of Investigational Agents ...

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