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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary Appendix C Letter from John Niederhuber, Director of the National Cancer Institute, to Members of the National Cancer Policy Forum
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service National Institutes of Health National Cancer Institute Bethesda, Maryland 20892 JUN 23 2008 Dear Forum Members: I am pleased to welcome everyone to the National Cancer Policy Forum’s Meeting on Multi-Center Phase III Clinical Trials and NCI Cooperative Groups. As we convene today, I know each of us is committed to making every effort to develop the latest scientific advances coming from our laboratories into clearly definable improvements in outcomes of cancer treatment. Over many years, our clinical trials system has served us admirably in that regard—in large part advanced and supported by various cooperative groups. Today, the very nature of biomedical science is rapidly changing, and as we move from non-specific, broadly toxic chemotherapies to combinations of highly targeted therapies, it has become imperative that our clinical trials enterprise be nimble enough to change, as well. We, as stewards of the nation’s health, must look beyond the horizon, in planning how future trials will need to be designed, managed and funded. The clinical trials system must be structured today to meet the challenges and requirements of tomorrow. I believe that we are faced with two major issues, in terms of designing a future structure for the most effective conduct of clinical research. First, the current system has, over time, become inefficient. It is duplicative, under-funded, and time consuming. Second, the system was designed during an era of non-specific mono-therapeutic and combination chemotherapeutic interventions. We do not have the capacity within the current structure to highly characterize each patient and carefully match that patient profile to the therapeutic combinations designed to target the specifically defined variation(s) that he or she may carry. To address these problems, we will need to design a trials structure that can obtain drug approval and demonstrate safety and benefit, just as the current system does; but it must also be a structure that will have the ability to incorporate multiple, specifically targeted agents optimally matched to the patient. Current, early phase trials for non-small cell lung cancer (NSCLC) provide a glimpse into the future of translational research: a notion of what we should strive to create as we, at the forum, undertake the redesign of the clinical trials system. The investigation into the various EGFR mutations that affect therapeutic efficacy of the EGFR tyrosine kinase inhibitors has allowed us to specifically target the agents to the mutations known to respond to this therapy. It has led to investigations into mechanisms of resistance; it has allowed the design of agents that may overcome such resistance. My hope is that, by the end of this meeting, we will have identified the building blocks of a system appropriate to this new era of drug discovery, efficacy demonstration, and FDA approval: a new structure that will at least begin to remove the barriers that have been identified.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary I am very much looking forward to discussing these ideas with you, and hope that together we are able to address this issue for the benefit of those fighting the battle with cancer, now and in the years ahead. Sincerely, John E. Niederhuber, M.D. Director National Cancer Institute
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