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

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permitted, and if so, at what sites. For ancillary studies, this section should include information regarding the choice of tumor sampling technique. For example, will aspiration biopsies be sufficient, or will surgical samples be required How much tissue will be needed What measures will be imposed to assure that the histopathologic diagnosis is not compromised How will issues of tumor heterogeneity be addressed What biases may be introduced by the sampling techniques and the amount of tissue required for the studies proposed 7.2.6 Pharmaceutical Information A separate pharmaceutical section is required for each agent. The content of the pharmaceutical section is dependent on whether the agent is investigational or commercial. A Pharmaceutical Data Sheet (PDS) is prepared by Pharmaceutical Management Branch (PMB) for most investigational agents. Regardless of whether the PMB data sheet is used, the following information about an agent is required in the protocol. Investigational Agent Pharmaceutical Section This section should include the following: • Product Description-Include the available dosage forms, ingredients, and packaging as appropriate. Also state the agent's supplier. For investigational agents sponsored by the Division of Cancer Treatment and Diagnosis, NCI, the supplier will be NCI and CTEP will have prepared a Pharmaceutical Data Sheet suitable for copying and pasting into the document as the pharmaceutical section for that agent. • Solution Preparation (how the dose is to be prepared)-Include reconstitution directions and directions for further dilution if appropriate. • Storage Requirements-Include the requirements for the original dosage form, reconstituted solution and final diluted product, as applicable. • Stability-Include the stability of the original dosage form, reconstituted solution and final diluted product, as applicable. • Route of Administration-Include a description of the method to be used and the rate of administration if applicable. For example, continuous intravenous infusion over 24 hours, short intravenous infusion over 30 to 60 minutes, intravenous bolus, etc. Describe any precautions required for safe administration. Commercial Agent Pharmaceutical Section This section should include the following: • Product description: State the agent’s supplier, i.e., commercially available. • Preparation (how the dose is to be prepared): Investigators may refer the reader to the package insert for standard preparation instructions. If the agent is to be prepared in a ‘non-standard’ or protocol-specific fashion, the reconstitution directions and instructions for further dilution must be included. Appropriate storage and stability information should be included to support the method of preparation. • Route of administration: Briefly describe how the agent will be administered in this protocol. For example, continuous intravenous infusion over 24 hours, short intravenous infusion over 30 to 60 minutes, intravenous bolus, etc. • Adverse Events: The investigator may refer the reader to the agent’s package insert. Note: The Informed Consent document should contain a list of all Section 7 - Investigator’s Manual 2009 34
expected adverse events that the patient is likely to experience. All adverse events in the informed consent should be written in laymen’s terms. 7.2.7 Treatment Plan Describe the protocol treatment clearly so all staff involved in the treatment of patients and in the conduct of the study can follow it. See Appendix IX, Guidelines for Treatment Regimens: Expression and Nomenclature. 7.2.8 Procedures for Patient Entry on Study Procedures for patient entry, whether randomized or nonrandomized, should be specified. Required information includes a description of the randomization process and the patient characteristics and stratification factors (if any) to be provided at the time of entry. Patients must be registered on study prior to beginning treatment. 7.2.9 Adverse Events List and Reporting Requirements Include a list and description of the Reported Adverse Events and Potential Risks observed in pre-clinical and clinical studies. This information can be found in the Investigators Brochure for investigational agents or the package insert for commercial agents. For investigational agents supplied by CTEP, DCTD, the Comprehensive Adverse events and Potential Risks list (CAEPR) and Agent Specific Adverse Event List (ASAEL) must be included. Instructions for reporting adverse events should be included in the protocol text, both for routine adverse event reporting as well as the expedited reporting of serious adverse events. (See Section 11) 7.2.10 Dose Modification for Adverse Events The plan of dose change for adverse events should be stated for each study agent. Dose modification criteria should be described in terms of NCI Common Terminology Criteria for Adverse Events (CTCAE). Protocol Authors must carefully review all investigational agents Investigator’s Brochures, ASAEL as well as CTEP’s “Comprehensive Adverse Events and Potential Risks” list (CAEPR) to be sure that they have included all reasonable measures to monitor expected adverse events. If the protocol includes an agent for which CTEP has prepared a CAEPR and ASAEL, the investigator must include the CAEPR and ASAEL in the protocol even if CTEP is not supplying the agent. These documents must be in the format provided and must be unaltered. 7.2.11 Criteria for Response Assessment The criteria for scoring responses should be included. These should be specific for both measurable and evaluable disease. Disease-specific criteria are often required and should clearly indicate acceptable means of measurement, i.e., CAT scans, radionuclide scans, ultrasound, etc. 7.2.12 Monitoring of Patients Specify how patients will be followed for assessment of treatment-related adverse events and therapeutic effect. A table of follow-up parameters that incorporates the schedule is particularly useful. The current version of the Common Terminology Criteria Section 7 - Investigator’s Manual 2009 35
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 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: at the FDA, and for the listing of
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
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• Agent preparations must be perf
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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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A Manual for Participants in Clinical Trials of Investigational Agents ...

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