Basic Knowledge and Practical Consideration of Phase I Trials in Oncology

Information on the topics listed on this slide will be presented in the lecture.1. First administration of novel anticancer drugs in human.2. Determining the optimal dose and administration method.3. Dose escalation test using toxicity as an index.

Responsibilities of principal investigators and important personnel in Phase I clinical trial team

Information on the topics listed on this slide will be presented in the lecture.Responsibilities of principal investigators in Phase I clinical trials involve:・Requirements of a principal investigator・Sub-investigators and clinical trial collaborators・Selection of prospective patients・Responsibilities toward patients・Deviation from protocol・Case report forms・Adverse drug reports during clinical trials・Discontinuation of clinical trialsImportant personnel in Phase I clinical trial team involve:・Organization of personnel introduced in the first half・Clinical trial coordinators・Nurses and laboratory technicians

Evaluation of non-clinical trials related to Phase 1 trials

Information on the topics listed on this slide will be presented in the lecture.・Overview of Phase I clinical trials・ICH Guidelines・Determining the initial dose・Verifying safety in non-clinical studies

Current trends in Phase I trials

Information on the topics listed on this slide will be presented in the lecture.1. History of pharmaceutically approved anti-cancer drugs.2. Changes in drugs, trial design, and target diseases in Phase I trials.3. Rationale underlying changes in anti-cancer drug categories.