Approaches to Phase 1 Clinical Trial Design Focused on Safety , Efficiency , and Selected Patient Populations : A Report from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug
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Authors' A Research Cancer Tre Maryland; University o Correspon cer Therapy nosis, 613 301-496-11
منابع مشابه
Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee.
The goals and objectives of phase 1 clinical trials are changing to include further evaluation of endpoints such as molecular targeted effects, in addition to dose-toxicity profile of the investigational agent. Because of these changes in focus, the National Cancer Institute and Investigational Drug Steering Committee's Task Force on Clinical Trial Design met to evaluate the most efficient ways...
متن کاملSafety, Efficiency, and Selected Patient Populations: A Report from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee
Authors' A Research Cancer Tre Maryland; University o Correspon cer Therapy nosis, 613 301-496-11
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The large number of negative phase III trials in oncology over the last several years has renewed interest in refining phase II oncology clinical trials to maximize the chances of success in phase III testing. More efficient phase II study designs will improve our ability to identify promising agents for testing while accurately identifying nonefficacious agents. Recognizing that new paradigms ...
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Phase I clinical trials represent the first step in bringing promising new treatments from the laboratory to the clinic. Although the importance of phase I clinical trials is widely recognized, there is currently no consensus among the scientific, medical, and statistical communities on how best to do these studies in humans. With the advent of targeted therapies, it has become evident that we ...
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تاریخ انتشار 2010