Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Introduction
Introduction
Pages 1-4
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Because of the public and academic nature of the collective groups, it has been possible for them to conduct clinical trials that extend beyond the usual focus and capacity of pharmaceutical companies, including trials on methods of cancer prevention and early detection, the comparative effectiveness of treatments, and how treatments affect patients' quality of life or long-term health, as well as trials that use new trial designs for combination therapies and proof-of-concept studies. In addition, the cooperative groups' infrastructure provides a valuable resource for industry to use for the clinical evaluation of commercial drug candidates.
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The trials must deal with cumbersome and complex processes, including trial planning and start-up; scientific, regulatory, and ethics review; staff participation; patient accrual; trial monitoring; and financial management. Inefficiencies in these processes, which greatly prolong the period of trial design and approval as well as erode financial support and increase regulatory burdens, have hampered the ability of the cooperative group Phase III trials program to achieve its goals.
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John Niederhuber, director of the NCI, focused his introductory remarks on the recent paradigm shift in cancer treatment from "search and destroy" nonspecific and broadly toxic treatments to "target and control" combinations of therapies that are specifically targeted to the genetic or molecular defects that underlie a patient's cancer. Using lung cancer as an example, he noted that researchers discovered specific genetic mutations of the epidermal growth factor receptor that are linked to how well a patient responds to the targeted cancer treatments gefitinib and erlotinib; researchers have also identified the mechanisms of resistance
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Such characterization may be done within the cancer genome characterization centers, which are currently part of the Cancer Genome Atlas pilot project of the NCI and the National Human Genome Research Institute, or within a similar setup, Dr. Niederhuber suggested. He also referred attendees to two relevant documents published by the NCI.
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