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NCI/FDA WILL CLARIFY MEANING OF PHASE II, III TRIALS, FDA

Executive Summary

NCI/FDA WILL CLARIFY MEANING OF PHASE II, III TRIALS, FDA Commissioner Young told the President's Cancer Panel at a Dec. 11 meeting in Bethesda, Md. The National Cancer Institute and the Food and Drug Administration will work together to clarify the differences between Phase II and Phase III trials, he said. Young said that in the future the two agencies will also address cancer trial endpoints, focusing on both specific tumors and general issues. "We particularly want to help develop meaningful quality-of-life and tumor symptom endpoints," Young stated. The two agencies have been collaborating over the past year on cancer treatment issues. The reapproachement between NCI and FDA arose during discussions of the Lasagna committee, also known as the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS. At the first meeting of the committee last January, NCI and FDA agreed to form a task force to resolve ongoing disputes, such as efficacy endpoints for cancer drugs. Describing the progress made to date, Young noted that FDA drug reviewers now participate in clinical protocol reviews at NCI's Cancer Therapy Evaluation Program. In turn, NCI personnel are invited to weekly meetings of FDA's oncology review staff and "often participate in FDA's meetings with industry on specific drugs." Young said NCI officials are also being invited to meetings of the agency's oncology drugs advisory committee. In the area of basic science, Young noted that FDA's Division of Cytokine Biology in the Center for Biologics Evaluation and Research has been working with NCI's Biological Response Modifiers Program and Cancer Therapy Evaluation Program on endpoints for colony stimulating factor (CSF) studies. Young said the agencies have been studying the effects of CSF on bone marrow transplants and dose intensification regimens for cancer chemotherapy. He also reported that an FDA/NCI fellowship training program for physicians will begin in July.

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