Clinical Research Training II
| Numbering Code | P-PUB01 8H147 PB90 | Year/Term | 2022 ・ Intensive, year-round | |
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| Number of Credits | 2 | Course Type | Practical training | |
| Target Year | Target Student | |||
| Language | Japanese and English | Day/Period | Intensive | |
| Instructor name |
TANAKA SHIROU (Graduate School of Medicine Program-Specific Professor) Morita Satoshi (Kyoto University Hospital Professor) ABE HIROYASU (Kyoto University Hospital Assistant Professor) NAKAKURA Akiyoshi (Kyoto University Hospital Program-Specific Assistant Professor) OOMAE KATSUHIRO (Part-time Lecturer) ASAKURA KOUKO (Part-time Lecturer) HIDAKA YU (Kyoto University Hospital Assistant Professor) UENO KENTARO (Kyoto University Hospital Program-Specific Assistant Professor) |
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| Outline and Purpose of the Course | This training facilitates a hands-on understanding of how the statistical thinking acquired in the Clinical Statistician Training course can be applied to real-word situations through practical training at a hospital. From this practical experience, students will understand the roles and responsibilities of test statisticians in clinical trials, and will be equipped with the fundamental capabilities (attitude, skills, knowledge) necessary for one to plan, conduct, and report on clinical trials as a test statistician. Clinical Research On-Site Practicum II continues from I, and offers more advanced content. Training will take place at two locations: Kyoto University Hospital and the National Cerebral and Cardiovascular Center. Students are asked to choose the facility they wish to train at in advance. Training at the Kyoto University Hospital mainly comprises planning and conducting clinical trials for the development of innovative new medical technologies (pharmaceuticals, etc.). Training takes place at two locations: Kyoto University Hospital and the National Cerebral and Cardiovascular Center. Details of the training will be published on the website. | |||
| Course Goals |
* Understand the process of planning and conducting clinical trials, the operation and system for carrying out clinical trials, and the roles and areas of responsibility of researchers, research assistants, and test statisticians. * Understand the statistical items that are to be included in clinical trial protocols and obtain the fundamental knowledge and techniques needed in order to contribute to the creation of clinical trial protocols. * Gain fundamental knowledge and skills to plan and carry out a statistical analysis appropriately and summarize the results. * Understand the fundamentals of research ethics and conflicts of interest in clinical trials and the protection of personal data, and learn to contribute to the planning and execution of reliable clinical trials. * Learn to use various explanatory methods and means and the attitudes and methods to convey statistical concepts in clinical trials in a way that is easily understood. |
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| Schedule and Contents |
Kyoto University Hospital Intensive lectures and practicums will be held over five days between July and September (Planned) (Periods 1-6, 8:45 - 19:45) Day 1: Period 1: Pre-Training Preparation Period 2: Advanced presentation and discussion of assignments Period 3: Standard Operating Procedures Period 4: Introduction to Real Clinical Trials by a Clinician Period 5-6: Protocol Creation and Database Construction Day 2 Period 1: Pre-Training Preparation Protocol 2: Presentation and discussion of the results of the protocol practicum Period 3-6: Statistical analysis planning practicum Day 3 Period 1: Pre-Training Preparation Period 2: Presentation and discussion of statistical analysis planning Period 3: SAS Program practicum Period 4: Validating the quality of the results of statistical analysis Periods 5-6: Statistical analysis practicum Day 4 Period 1: Pre-Training Preparation Period 2: Summary Reports Period 3: Clinical Trial Report Paper Practicum Periods 4-6: Statistical Analysis Report Practicum Day 5 Periods 1-2: Pre-Training Preparations Periods 3-4: Statistical Analysis Report Presentation Period 5: Conclusion Period 6: Report Creation National Cerebral and Cardiovascular Center This will be held over a total of six days. Held between July and September (Each session lasts for 90 minutes) (9:30-11:00/11:15-12:45/13:45-15:00/15:15-17:00)． Day 1 Session 1: Training Overview and Explanation, Visit to a Hospital: Purpose and Content of Training Session 2: Cardiovascular Disease Fundamentals (1): The Basics of Cerebrovascular Disease Session 3: Cardiovascular Disease Fundamentals (2): The Basics of Cranial Nerve Disease Session 4: Ethics and Patient Consent Day 2 Session 5: Statistical Analysis (1): Basic Matters in Statistical Analysis Session 6: Statistical Analysis (2): Tasks and Procedures in Statistical Analysis Session 7: Statistical Analysis Reports, Summary Reports, and the Publication of Papers Session 8: Statistical Analysis Consultation and Clinical Trial Consultation Day 3 Session 9: Data Management for Clinical Trials: The Fundamentals of Data Management Session 10: Data Management for Clinical Trials: Data Management Tasks and Processes Session 11: Group Work (1): Data Management Exercise (1) Session 12: Group Work (2): Data Management Exercise (2) Day 4 Session 13: Group Work (3): Data Management Exercise (3) Session 14: Group Work (4): Data Management Exercise (4) Session 15: Group Work (5): Statistical Analysis Exercise (1) Session 16: Group Work (6): Statistical Analysis Exercise (2) Day 5 Session 17: Clinical Trial Monitoring Session 18: Clinical Trial Monitoring Field Trip Session 19: Group Work (7): Statistical Analysis Exercise (3) Session 20: Group Work (8): Statistical Analysis Exercise (4) Day 6 Session 21: Group Work (9): Statistical Analysis Exercise (5) Session 22: Group Work (10): Statistical Analysis Exercise (6) Session 23: Summary Presentation (1): Data Management Exercise Results Report Session 24: Summary Presentation (2): Statistical Analysis Exercise Results Report |
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| Evaluation Methods and Policy | Evaluation is based on the content of the reports and presentations created in practicums. Class participation (attendance, etc.) will also be taken into account. | |||
| Course Requirements | Students must have completed Clinical Research Practicum I. | |||
| Study outside of Class (preparation and review) | Indicated during practicums. | |||
| Textbooks | Textbooks/References | Not used | ||
| References, etc. | Other materials will be indicated during practicums. | |||
