Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI Table of Contents Part A 1 2 3 Part B 4 5 6 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices Part E: Nonresearch or Treatment Referral Protocol Use of Investigational Agents 17. Group C 17.1 Definition 17.2 Placement of an Agent in Group C 17.3 Current Group C Agents 17.4 Use of a Group C Agent 17.5 Requesting a Group C Agent 17.6 Responsibilities When Using Group C Agents 17. Group C 17.1 Definition Investigational agents that have been given Group C designation by FDA have reproducible efficacy in one or more specific tumor types. Such an agent has altered or is likely to alter the pattern of treatment of the disease and can be safely administered by properly trained physicians without specialized supportive care facilities. 17.2 Placement of an Agent in Group C If an agent meets the criteria in the preceding paragraph, CTEP may initiate a formal application to the FDA to authorize Group C distribution for the specific indication. Such authorization is not equivalent to formal FDA approval of effectiveness for this indication. 17.3 Current Group C Agents A physician should request agents under Group C if he or she wishes to treat a patient with an indication specifically authorized for the requested agents, as listed in Appendix XIV. The list of current agents classified as Group C is subject to change as agents receive FDA approval. The Pharmaceutical Management Branch (PMB) may be contacted for the latest listing or for further information (Appendix IV). All other non-research requests for clinical use are considered a "Special Exception" (see Section 18). 17.4 Use of a Group C Agent The use of an agent for a Group C-approved indication is fully described in the GUIDELINE PROTOCOL. This document is written by CTEP and approved by FDA. It describes the indications, dosage, precautions, warning, and known adverse effects of the agent for the specific indications(s). It also contains a FDA-approved informed consent, which must be used if there has been no local IRB review. Guideline protocols may be obtained by contacting the Pharmaceutical Management Branch (PMB) at the address listed in Appendix IV. Additional information is available by phone at the number listed in Appendix IV. Please note that: Patients treated under Group C guidelines are not part of a clinical trial at the time of the treatment with the Group C agent. An agent classified in Group C for a certain indication may still be under active clinical investigation for the same or other indications. Group C must not be used to obtain agent to conduct clinical trials. 17.5 Requesting a Group C Agent You may request a Group C agent by contacting the Clinical Research Pharmacy Section, PMB, by telephone or in writing. (See Appendix IV for number and address). The amount of patient information required varies specifically for each Group C agent. Physicians should contact the PMB for the specific requirements. You must have a current FDA Form 1572, Supplemental Investigator Data Form, Financial Disclosure Form, http://ctep.cancer.gov/forms/index.html, and CV on file with CTEP (i.e., signed within the last 12 months). If your request is approved you will receive a supply of the investigational agent and an approval letter, a copy of the Guideline Protocol, and procedures for reporting adverse events. Reporting requirements for Group C agents vary depending on the investigational agent and are specified in the protocol for the agent. 17.6 Responsibilities When Using Group C Agents Agent Accountability: You must record the disposition of investigational agents received on the Agent Accountability Record Form (Section 15 and Appendix XII). Adverse Events: Since Group C agents are still investigational agents, physicians using them are obligated to report adverse events to CTEP (Section 11). Informed Consent: You must obtain written consent from the patient. The Guideline Protocol contains the required consent form. IRB Review: Since administration of an investigational agent under Group C guidelines is not done with a primary research intent, an IRB waiver has been obtained from FDA for most Group C agents. You should, however, check with your IRB to determine whether its local policies require approval. In the future, CTEP will consider Group C classification only for those agents whose activity is well enough established that NDA or BLA approval in the relatively near future is considered likely. Table of Contents Part A 1 2 3 Part B 4 5 7 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices

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