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| Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents
Part D: The Organization of a Clinical Trial14. Who May Administer Investigational Agents
14. Who May Administer Investigational Agents 14.1 Restrictions to Physicians Registered as Investigators with CTEP The distribution of investigational agents is restricted to physicians who are registered as investigators with CTEP. Specifically, the secondary distribution of investigational agents from registered investigators to unregistered physicians is prohibited. All patients on clinical trials involving the use of investigational agents must receive all treatments with these agents from a registered investigator. The reason for this policy is clear. Physicians who treat patients as part of a clinical trial must have a commitment to the goals of the trial and to the methodologic requirements of clinical research. They must be experienced in the evaluation of therapeutic results and of the adverse event manifestations of anticancer therapy. The major issue, therefore, in the conduct of a clinical trial is: Who is making the observations and the decisions? For example, who is deciding on the dose modifications and the laboratory tests to be obtained? Who is observing the patient for adverse events of the investigational agents? A physician performing these tasks with investigational agents must have the training and experience to function effectively as a clinical investigator, and acknowledge his or her commitment to those principles. All investigators participating in trials sponsored by CTEP must be formally registered with their research base (i.e., Cooperative Group or Cancer Center) and with CTEP. Such registration signifies that the physician-investigator meets certain requirements for participation in clinical trials. Investigators register with CTEP by completing a FDA Form 1572, a Supplemental Investigator Data Form, and a Financial Disclosure Form, http://ctep.cancer.gov/forms/index.html, (Appendix V). Physicians in training may administer investigational agents under the direct supervision of a registered investigator holding a current FDA Form 1572. They need not submit a FDA Form 1572 under their own signature. In such cases, the registered investigator assumes complete responsibility for the use of these agents. CTEP recognizes that it is often convenient for a Cooperative Group member or Cancer Center physician to ask a local physician to administer protocol treatment to a patient who may have traveled long distances to the research base for initial consultation. We believe that this approach is ultimately detrimental to the clinical research effort unless very careful surveillance is maintained by the investigator. If close monitoring is impossible, it seems much more sensible to require that all treatments be administered by registered investigators. Physicians will have to carefully consider whether a patient being evaluated for study will be able to receive each treatment at the hands of a registered physician. We are confident, however, that the benefits of this policy, in terms of both patient safety and integrity of the research data, far outweigh the disadvantages and are in the long term best interests of both patients on clinical trials and the agent development program of the DCTD.
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