Multiplicity in clinical trials
| Numbering Code | P-PUB01 8H145 LB90 | Year/Term | 2022 ・ The first half of first semester | |
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| Number of Credits | 1 | Course Type | Lecture | |
| Target Year | Professional degree students | Target Student | ||
| Language | Japanese and English | Day/Period | Fri.2 | |
| Instructor name |
SATO TOSIYA (Graduate School of Medicine Professor) SAKAMAKI KENTARO (Part-time Lecturer) OMORI TAKASHI (Graduate School of Medicine Program-Specific Professor) Omiya Masatomo (Graduate School of Medicine Program-Specific Assistant Professor) |
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| Outline and Purpose of the Course |
Multiple validation tests are often necessary within a single clinical trial, such as in a confirmatory clinical trial in which multiple doses of a study drug are run and compared to a placebo group. In such cases, it is extremely important to perform analysis that considers the multiplicity of the type-1 error rare (α error) properly. In this course, we aim to make students capable of considering the multiplicity of tests at each stage of a clinical trial, namely planning, analysis, and the interpretation of results. Some practical training will also be provided using SAS. The fifth session will be delivered by Professor Isao Yokota of Hokkaido University, and the seventh session will be delivered by Professor Kouhei Uemura of the University of Tokyo. [Lecture format, using PowerPoint slides] |
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| Course Goals |
・Gain skills to distinguish between cases where adjustment for test multiplicity is necessary and cases where it is not. ・Understand basic statistical methods and learn to choose appropriate methods. ・Learn to analyze real data using basic statistical methods using SAS procedures. ・Learn to evaluate the performance of each method using Monte Carlo simulations. |
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| Schedule and Contents |
Session 1, April 10, Period 2: Fundamentals of Test Multiplicity of (Doi) Session 2, April 17, Period 2: Overview of Basic Statistical Methods (Doi) Session 3, April 24, Period 2: Closed Testing Procedure (Doi) Session 4, May 1, Period 2: Practicum using SAS (Doi, Omiya, Imai) Session 5, May 8, Period 2: Interval Analysis (Yokota) Session 6, May 15, Period 2: Multiplicity (Doi) in Subgroup Analysis and Dose-Response Relationship Studies (Doi) Session 7, May 29, Period 2: The Application of Multiplicity Adjustment in Practice (Uemura) |
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| Evaluation Methods and Policy | Class participation and reports. | |||
| Course Requirements |
・Students must have completed the "Fundamentals of Statistical Inference" course. ・Students must be familiar with data handling and random number generation in SAS. |
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| Study outside of Class (preparation and review) | Students should review the content of the "Fundamentals of Statistical Inference" course and CB course students should review the content of the "Practical Skills for Clinical Statisticians" course thoroughly. Students must review the lessons learned in each lecture. | |||
| Textbooks | Textbooks/References | Lecture materials will be distributed. | ||
| References, etc. | Yasushi Nagata. (2007) "統計的多重比較法の基礎" (Scientist Ltd.) ISBN:978-4914903466, Kentaro Sakamaki, Takashi Sozu and Toshimitsu Hamasaki, "多重比較法" (Asakura Shoten) ISBN: 978-4254128628, Dmitrienko, A., Molenberghs, G., Chuang-Stein, C., & Offen, W. W. (2005) "Analysis of clinical trials using SAS: A practical guide." (SAS Institute), translated by (Kaoru Morikawa and Tasaki Takenobu (2009)) 治験の統計解析 –理論とSAS®による実践, Kodansha), Dmitrienko, A., Tamhane, A. C., & Bretz, F. (Eds.). (2009) "Multiple testing problems in pharmaceutical statistics." (CRC press) | |||
