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

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4.2.1 Cooperative Agreement Awardees or Contractors........................................15 4.2.2 Other Phase 1 Investigators ..........................................................................16 4.3 Which Organizations Can Conduct Phase 1 Studies ................................................16 4.4 Who Is Eligible to Administer Phase 1 Agents ..........................................................16 4.5 How to Obtain Information about Phase 1 Agents ....................................................16 4.5.1 Investigator’s Brochure..................................................................................16 4.5.2 Investigational Drug Branch (IDB) Physicians ...............................................16 4.5.3 Career Development LOI...............................................................................17 4.5.4 Other Information...........................................................................................17 5 Phase 2 Trials....................................................................................................................18 5.1 New Agent Development Considerations..................................................................18 5.1.1 Planning and Coordination of Phase 2 Trials by CTEP....................................18 5.1.2 Single Agent Phase 2 Studies..........................................................................18 5.1.3 Combining Agents ............................................................................................20 5.1.4 Randomized Phase 2 Studies ..........................................................................21 5.2 Protocol Considerations ............................................................................................21 5.2.1 Single Disease Studies.....................................................................................21 5.2.2 Eligibility Requirements ....................................................................................21 5.2.3 Accrual and Statistical Considerations .............................................................22 5.3 Which Organizations can Conduct Phase 2 Studies...............................................22 5.3.1 Cooperative Groups.......................................................................................22 5.3.2 Cancer Centers..............................................................................................22 5.3.3 Affiliates .........................................................................................................23 5.3.4 New Agent Development Contractors and Cooperative Agreement and Grant Awardees.............................................................................................23 5.3.5 Multicenter Phase 2 Trials .............................................................................23 5.4 Who is Eligible to Administer Phase 2 Agents...........................................................23 5.5 Restriction on Participation in Phase 2 Studies.........................................................23 5.6 How to Obtain Information about Phase 2 Agents ....................................................24 5.6.1 Investigator’s Brochure..................................................................................24 5.6.2 IDB Physicians...............................................................................................24 5.6.3 Clinical Research Pharmacists......................................................................24 6 Phase 3 Trials....................................................................................................................25 6.1 Scientific Policies of CTEP ........................................................................................25 6.2 Who Is Eligible to Conduct Phase 3 Trials ................................................................25 6.3 Eligibility Requirements .............................................................................................26 6.4 Coordination of Planning with the Clinical Investigations Branch (CIB), CTEP.........28 6.5 Cancer Trials Support Unit (CTSU)...........................................................................29 7 The Letter of Intent and Drafting of a Protocol .........................................................30 7.1 The Letter of Intent (LOI)...........................................................................................30 7.1.2 Definition........................................................................................................30 Table of Contents - Investigator’s Manual 2009 ii
7.1.3 Purpose .........................................................................................................30 7.1.4 Ground Rules for the LOI System..................................................................30 7.1.5 Submission of LOIs........................................................................................31 7.1.6 Review of LOIs ..............................................................................................31 7.1.7 CTEP LOI Review Criteria.............................................................................31 7.1.8 After LOI Approval .........................................................................................32 7.1.9 Information about the Status of an LOI..........................................................32 7.1.10 CTEP Career Development LOI ....................................................................32 7.2 The Drafting of a Protocol .........................................................................................32 7.2.1 Title Page.......................................................................................................32 7.2.2 Schema .........................................................................................................33 7.2.3 Objective(s)....................................................................................................33 7.2.4 Background and Rationale ............................................................................33 7.2.5 Patient Eligibility Criteria................................................................................33 7.2.6 Pharmaceutical Information...........................................................................34 7.2.7 Treatment Plan ..............................................................................................35 7.2.8 Procedures for Patient Entry on Study ..........................................................35 7.2.9 Adverse Events List and Reporting Requirements........................................35 7.2.10 Dose Modification for Adverse Events...........................................................35 7.2.11 Criteria for Response Assessment ................................................................35 7.2.12 Monitoring of Patients....................................................................................35 7.2.13 “Off-Study” Criteria.........................................................................................36 7.2.14 Statistical Considerations ..............................................................................36 7.2.15 Records to be Kept........................................................................................36 7.2.16 Participation...................................................................................................36 7.2.17 Multicenter Trials ...........................................................................................37 7.3 Informed Consent......................................................................................................38 7.4 Protocol Templates ...................................................................................................39 8 Protocol Review and Approval at CTEP .....................................................................40 8.1 The Protocol and Information Office (PIO) ................................................................40 8.2 How to Submit a Protocol..........................................................................................40 8.3 IRB Approval .............................................................................................................40 8.4 Protocol Review ........................................................................................................41 8.4.1 Scheduling the Protocol for Review...............................................................41 8.4.2 Review by the CTEP Protocol Review Committee ........................................41 8.4.3 The Review of the Protocol............................................................................41 8.4.4 The Review of the Informed Consent ............................................................42 8.4.5 The Review of Regulatory and Administrative Concerns ..............................42 8.4.6 The Review by the Pharmaceutical Collaborator...........................................42 8.4.7 The Consensus Review.................................................................................42 8.4.8 Responding to CTEP Consensus Review .....................................................42 8.5 Protocol Document Approval.....................................................................................43 8.6 Amendments .............................................................................................................43 8.7 Study Status ..............................................................................................................43 8.8 Reactivation of Studies..............................................................................................44 Table of Contents - Investigator’s Manual 2009 iii
Page 1: A Manual for Clinical Investigators
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 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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