Statistical Methods in Clinical Trials
| Numbering Code | P-PUB01 8H135 LJ90 | Year/Term | 2022 ・ Intensive, Second semester | |
|---|---|---|---|---|
| Number of Credits | 1 | Course Type | Lecture | |
| Target Year | Professional degree students | Target Student | ||
| Language | Japanese | Day/Period | Intensive | |
| Instructor name |
TANAKA SHIROU (Graduate School of Medicine Program-Specific Professor) Omiya Masatomo (Graduate School of Medicine Program-Specific Assistant Professor) |
|||
| Outline and Purpose of the Course | We hold lectures and practical training with the aim of understanding the design of Phase II and Phase III clinical trials and learning sample size calculations. Lecture videos and assignments will be distributed before the first session, so students should use them for preparation and review. Knowledge of clinical trials and statistics equivalent to the first semester courses "Clinical Trials," "Fundamentals of Statistical Inference," and "Statistical Models and their Applications" is a prerequisite. This is a mandatory course for CB and an elective course for MPH. | |||
| Course Goals |
・Learn to calculate sample sizes in Phase II and Phase III clinical trials. ・Understand frequency theory in study design and the differences from Bayesian statistical concepts. |
|||
| Schedule and Contents |
・Classes will be held in Seminar Room B in Building G. ・Homework + lecture and practicum format. ・Homeworks are provided using an online learning environment KoALA (https://koala.highedu.kyoto-u.ac.jp). ・We calculate sample size in the practicums in Sessions 1 to 4, but no knowledge of software is assumed. In Sessions 6 and 7, we read clinical trial papers and interpret results. ・Practicum tutoring is performed by clinical statistics staff. Session 1, October 6: Sample Size Design 1 Continuous Data (Tanaka, Imai, Yada) Session 2, October 13: Sample Size Design 2 Binary Data (Tanaka, Imai, Yada) Session 3, October 20: Interpreting the Results of Clinical Trials (Tanaka, Imai, Yada) Session 4, October 27: Interpreting the Results of Clinical Trials (Tanaka, Imai, Yada) Session 5, November 10: Sample Size Design 3 Survival Time Data (Tanaka, Imai, Yada) Session 6, November 17: Sample Size Design 4 Phase II Clinical Studies, Bayesian Statistics (Tanaka, Imai, Yada) Session 7, November 24: Reserve date |
|||
| Evaluation Methods and Policy | Class participation: 50% and Reports: 50% | |||
| Course Requirements | Students must have completed the following courses in the first semester: "Clinical Trials," "Fundamentals of Statistical Inference," and "Statistical Models and their Applications." | |||
| Study outside of Class (preparation and review) | Prepare for and review lessons using the lecture videos and assignments distributed before the first session. Details will be announced via email. | |||
| Textbooks | Textbooks/References | Machin D, Campbell MJ, Tan SB, Tan SH. "Sample Sizes for Clinical, Laboratory and Epidemiology Studies, 4th Edition," (John Wiley & Sons). We will make an announcement on acquiring textbooks during Session 1. | ||
