Gynecologic oncology
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The vast number of novel targeted therapies available for testing in the United States dictates that a more efficient system aimed at identifying promising agents for phase III testing needs to be developed. Alternatives to traditional phase II trial design including alternative end points, randomized designs, biomarkers, and imaging tools are discussed. ⋯ Alternatives to traditional phase II trial design including alternative end points, randomized designs, biomarkers, and imaging tools should allow ineffective agents to be discarded and promising agents to undergo further investigation.
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Gynecologic oncology · Feb 2010
ReviewNIH and NCI support for development of novel therapeutics in gynecologic cancer: a user's guide.
The development of novel therapeutics is a lengthy and often tortuous process. It frequently spans the identification of new targets, preclinical validation, discovery and refinement of novel therapies, safety studies, phase O, 1, 2, and 3 trials, and reverse translation. NIH and NCI provide via web sites a variety of resources and research tools of great value to investigators. ⋯ The NCI's effective partnership with industry and academia, as well as the ongoing NCI-supported clinical trials network, facilitates clinical development of novel therapeutics. Specialized NCI programs focused on cancer imaging, radiation research, and complementary and alternative medicine, also assist the development of novel agents. Finally, the NIH and the NCI sponsor a variety of grant mechanisms, supporting institutions, consortia, and individuals, which investigators seeking to develop novel therapeutics should make themselves familiar.