The Phase III Clinical Cancer Trial

摘要: Phase III clinical trials in oncology represent the final step a multistage process of evaluating role new drug, combination regimen, or other treatment modality cancer setting. In United States, these are often conducted by large cooperative groups with support from National Cancer Institute (NCI). Some were founded 1960s, and many now have world-wide site affiliations. The major conducting phase adult pediatric hematological malignancies solid tumors States listed Table 1. compare drug to therapy regarded as standard care specific Commercial sponsors play an active conduct trials, either assuming direct responsibility for trial design implementation through agreements groups. Input on is sought regulatory bodies such U.S. Food Drug Administration (USFDA), European Agency Evaluation Medicinal Products (EMEA), Japanese authorities, owing potential impact some trials. design, conduct, outcome analysis complex interaction among academic institutions, groups, commercial sponsors, bodies.