Statisticians Standard of Conducts
| Numbering Code | P-PUB01 8H134 LJ90 | Year/Term | 2022 ・ Intensive, First semester | |
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| Number of Credits | 1 | Course Type | Lecture | |
| Target Year | Professional degree students | Target Student | ||
| Language | Japanese | Day/Period | Intensive | |
| Instructor name |
SATO TOSIYA (Graduate School of Medicine Professor) SATOU KEIKO (Graduate School of Medicine Project Associate Professor) 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 | According to the 19th Century British Prime Minister Benjamin Disraeli, "There are lies, damned lies and statistics." However, statistics are used in various fields as fundamental information for decision-making and policy, and are vital to maintaining and improving human well-being and the environment. For statistics to not devolve into lies, statisticians, experts who perform research and tasks involving statistics, must not only have the appropriate knowledge and skills, but also professionalism. Saying this feels somewhat rigid, but as a result of recent instances of misconduct related to research, external regulations have only become stricter, such as mandatory attendance at research ethics seminars on standards adherence. This course aims to have students think for themselves about what statisticians should be, based on the basic premise that the only person who can ensure one's adherence is oneself. There is a need not only for science while designing clinical trials for humans, but also for heart. Medicines that were supposed to bring health have brought tragedy, and we shall study examples where statisticians may have been responsible for the harm caused. We shall consider how statisticians should behave, and what students wish to engage with through discussions and group work. [Online intensive lectures on July 2, 9, and 16 (Fri)] | |||
| Course Goals |
Understand ・Conflicts between science and ethics in clinical research, ・What statisticians have done in drug evaluations in the past, ・Ways to explain the role of statisticians in clinical research, and ・Ways to consider and internalize standards of behavior as a statistician. |
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| Schedule and Contents |
Intensive lectures: July 2 (Friday, Periods 3 and 4), 9 (Friday, Periods 3 and 4), and 16 (Friday, Periods 3, 4, and 5) Session 1, July 2, Period 3: Planning a Valid Clinical Trial 1 Session 2, July 2, Period 4: Planning a Valid Clinical Trial 2 Session 3, July 9, Period 3: The Thalidomide Law Suit and Statisticians 1 (Professor Tsugumichi Sato, Tokyo University of Science) Session 4, July 9, Period 4: The Thalidomide Law Suit and Statisticians 2 Session 5, July 16, Period 3: The Heart of the ICH Statistical Guideline Session 6, July 16, Period 4: Cultivating Professionalism Among Statisticians Session 7, July 16, Period 5: Group Work |
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| Evaluation Methods and Policy | Reports | |||
| Course Requirements | Students who are not statisticians are also welcome. | |||
| Study outside of Class (preparation and review) |
Read the "Statisticians' Code of Conduct" issued by The Biometric Society of Japan and the "Statistical Principles in Clinical Trials" issued by ICH E9. http://www.biometrics.gr.jp/news/all/standard_20150310.pdf https://www.pmda.go.jp/int-activities/int-harmony/ich/0031.html |
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| Textbooks | Textbooks/References | Materials will be distributed in each session. | ||
| References, etc. | Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB 『Fundamentals of Clinical Trials, 5th ed.』 (Springer, 2015), Hideo Kunitoh, Keiko Sato, Kenichi Yoshimura, "誰も教えてくれなかった癌臨床試験の正しい作法" (Chugai Igaku, 2016) | |||
