Phase 1 Trial Development Course
ATLAS (Asian clinical TriaLs network for cAncerS) project - Training Program
Phase 1 Trial Development Course
Target trainees: Physicians, clinical research coordinators and other relevant professionals who engage or would like to engage oncology phase 1 trials.
ATLAS (Asian clinical TriaLs network for cAncerS) project - Training Program
Phase 1 Trial Development Course
Target trainees: Physicians, clinical research coordinators and other relevant professionals who engage or would like to engage oncology phase 1 trials.
-
Basic Knowledge and Practical Consideration of Phase I Trials in Oncology
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
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
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
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.