Topic outline
Characteristics Of Cancer Clinical Trials (General)
1. Overview of clinical studies and clinical trials
2. Phase I trial
3. Phase II trial
4. Phase III trial
5. Recent trends in anticancer drug development1:00:09
The General Role Of CRCs In Cancer Clinical Trials
1. Role of CRC in Cancer Clinical Trials
2. Provide Support to Subjects Participating in Cancer Clinical Trials
3. Support for conducting Cancer Clinical Trials0:40:03
Support for multi-regional cancer clinical trials
1. Multi-regional Cancer Clinical Trial
2. CRC Support In MRCTs
3. Summary0:35:01
Review of cancer clinical trial protocols from a CRC perspective
1. Role and definition of the protocol
2. Perspective of CRC reading of the protocol
3. Uncomfortable situations when conducting clinical trials
4. Summary0:28:53
Supporting decision making in cancer clinical trials
1. What is decision-making?
2. Necessity of informed consent (IC) in clinical trials
3. Reality of supporting decision-making in cancer clinical trials
4. Decision-making in clinical trials of pediatric cancer0:40:24
Supporting participants in cancer clinical trials (Schedule, compliance, various tests)
Supporting participants in cancer clinical trials (Schedule, compliance, various tests)
1. Characteristics of patients participating in cancer clinical trials
2. Specific support for patients provided by CRCs
・Support before administration
・Support during administration
・Support after completing administration
3. Summary0:44:30
Supporting efficacy evaluation in cancer clinical trials: management and management tools
Supporting efficacy evaluation in cancer clinical trials: management and management tools
・What is efficacy in cancer clinical trials?
・Efficacy evaluation methods in cancer clinical trials
・CRC support for efficacy evaluation in cancer clinical trials
・Summary0:40:13
Supporting safety evaluation in cancer clinical trials (its management and management tools)
Information on the topics listed on this slide will be presented in the lecture.
・Purpose of safety evaluation
・What are adverse events?
・What is CTCAE?
・Causal relationship
・Actual support for safety evaluation
・SAE reporting0:48:38
Supporting phase 1 cancer clinical trials
Information on the topics listed on this slide will be presented in the lecture.
・Phase 1 Trials in Cancer Clinical Trials
・Preparation for Starting Clinical Trials
・Administration of Study Drug
・Summary0:32:39
The Role of CRC in QMS for Cancer Clinical Trials
Information on the topics listed on this slide will be presented in the lecture.
・Why QMS is needed in clinical studies.
・What is QMS?
・Role of CRC0:33:16