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| Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI
Part C: The Planning and Execution of a Clinical Trial
11. Adverse Events Because most antineoplastic agents have a very narrow therapeutic index, adverse events commonly accompany treatment. Since cancer patients often exhibit signs and symptoms referable to cancer or its complications, both the definition and identification of a medical event as an adverse event to a cancer agent present special problems for the investigator and sponsor. We have developed operational definitions and guidelines for reporting adverse events (AEs) that apply to anticancer agent trials (see http://ctep.cancer.gov/reporting/adeers.html, Appendix XI). The prompt reporting of AEs to the CTEP is the responsibility of each investigator engaged in clinical research with investigational agents supplied by the DCTD. Investigators are encouraged to submit reports even if there is only a suspicion of an agent effect. Timely and accurate reporting of AEs is necessary because only the sponsor can collate information from diverse sources and quickly disseminate the information to investigators working with the agent. The centralization of information on real or suspected AEs makes possible a much more accurate determination of the degree to which a suspected event is in fact agent-induced. Finally, regulations require DCTD to report to FDA all findings regarding AEs occurring in trials under its sponsorship. The DCTD Common Toxicity Criteria should be used in reporting adverse events on all DCTD-sponsored trials. A section giving detailed instructions for reporting adverse events should be included in each protocol document for DCTD sponsored trials. 11.1 Adverse Events with Commercially Available (Non-Investigational) Agents For studies sponsored or funded by NCI involving commercially available agents not provided under an IND, AEs should be reported in writing using the standard FDA adverse event reporting form (Form 3500, MedWatch) for unexpected life-threatening (Grade 4) or fatal (Grade 5) events. The specific reporting guidelines are available in Attachment B of the NCI Expedited Adverse Event Reporting Guidelines (See Appendix XI). 11.2 Adverse Events and Routine Reporting of Adverse Events The reporting of AEs is in addition to and does not supplant the reporting of adverse events as part of the regular scientific report of the results of the research protocol. Reporting of adverse events should be in accord with the procedures for reporting results described in Section 10. 11.3 Actions Taken by CTEP on AE Reports CTEP physicians review each submitted report, including the investigator's assessment. This review may result in a request for further information from the investigator. Each submitted AE report is classified according to its likely relation to the agent, and to the patient's underlying disease. Based on this assessment, a decision is made concerning the need for further action. The prime consideration is whether the new findings affect the safety of patients enrolled in ongoing trials. If so, CTEP takes immediate steps to notify the investigator community, the FDA and the collaborating pharmaceutical firm simultaneously. In addition, other measures may be taken, including:
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