The Phase III Trial in the Era of Targeted Therapy: Unraveling the “Go or No Go” Decision

摘要: Purpose: To review characteristics of contemporary phase III oncology trials and create an explicit framework to help clinical researchers prioritize novel therapies for testing. Methods: We searched the MEDLINE EMBASE databases all reviews trials; cataloged in two national trial databases; reviewed approval criteria recently approved drugs from public data provided by US Food Drug Administration. Industry not available elsewhere medical literature were obtained a sourcebook published large contract research organization. Results: Phase are most expensive time-consuming aspect drug development process. The results these continue exert greatest influence on treatment decision oncologists remain pivotal granting approval. Making optimal decisions about which agents advance testing may decrease overall cost...