Novel Designs and End Points for Phase II Clinical Trials

摘要: The large number of negative phase III trials in oncology over the last several years has renewed interest refining II clinical to maximize chances success testing. More efficient study designs will improve our ability identify promising agents for testing while accurately identifying nonefficacious agents. Recognizing that new paradigms trial need be developed, Clinical Trial Design Task Force National Cancer Institute (NCI) Investigational Drug Steering Committee tackled question improving efficiency trials. In this issue CCR Focus, four major topics discussed are presented. First, task force recommended alternate end points should studied. Second, depending on characteristics specific and population, historical controls or a randomized design may more appropriate. Third, rational incorporation biomarkers into encouraged. Last, novel imaging modalities critical evaluating benefit cytostatic