Outline of Clinical Trials on Cancer
This course provides basic knowledge of planning, outcome evaluation, and biostatistics for clinical trials on cancer for researchers willing to be principal investigators. The lectures in this course were translated from the seminar held for the Japan Clinical Oncology Group (JCOG) members in October 2020. For an overview of the framework of clinical trials on cancer, the first lecture in CRC Training Course, “Characteristics of Cancer Clinical Trials (General) ”, will also be a help for understanding.
1. Minimum statistical knowledge required for clinical trials on cancer (Part 1 and 2)
2. Designs for clinical trials on cancer (Part 1 and 2)
3. Response evaluation and adverse events (Part 1 and 2)
This course provides basic knowledge of planning, outcome evaluation, and biostatistics for clinical trials on cancer for researchers willing to be principal investigators. The lectures in this course were translated from the seminar held for the Japan Clinical Oncology Group (JCOG) members in October 2020. For an overview of the framework of clinical trials on cancer, the first lecture in CRC Training Course, “Characteristics of Cancer Clinical Trials (General) ”, will also be a help for understanding.
1. Minimum statistical knowledge required for clinical trials on cancer (Part 1 and 2)
2. Designs for clinical trials on cancer (Part 1 and 2)
3. Response evaluation and adverse events (Part 1 and 2)
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Minimum statistical knowledge required for clinical trials on cancer - Part 1 of 2
Minimum statistical knowledge required for clinical trials on cancer - Part 1 of 2
Some key points for interpreting the results of phase III randomized controlled trials are introduced in this lecture. Particularly, this part outlines survival curve and randomization.
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Minimum statistical knowledge required for clinical trials on cancer - Part 2 of 2
Minimum statistical knowledge required for clinical trials on cancer - Part 2 of 2
Some key points for interpreting the results of phase III randomized controlled trials are introduced in this lecture. Particularly, this part outlines verification and evaluation of results, and ITT analysis set.
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Designs for clinical trials on cancer - Part 1 of 2
Designs for clinical trials on cancer - Part 1 of 2
Development flow and clinical trial designs of anticancer drugs are introduced in this lecture. Particularly, this part outlines development flow and phase I clinical trial designs.
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Designs for clinical trials on cancer - Part 2 of 2
Designs for clinical trials on cancer - Part 2 of 2
Development flow and clinical trial designs of anticancer drugs are introduced in this lecture. Particularly, this part outlines phase II and III clinical trial designs.
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Response evaluation and adverse events - Part 1 of 2
Response evaluation and adverse events - Part 1 of 2
Methods for response evaluation and adverse event reporting used in clinical trials on cancer are introduced in this lecture. Particularly, this part outlines response evaluation.
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Response evaluation and adverse events - Part 2 of 2
Response evaluation and adverse events - Part 2 of 2
Methods for response evaluation and adverse event reporting used in clinical trials on cancer are introduced in this lecture. Particularly, this part outlines adverse event reporting.