Clinical Research Training I
| Numbering Code | P-PUB01 8H140 LB90 | Year/Term | 2022 ・ Intensive, year-round | |
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| Number of Credits | 2 | Course Type | Practical training | |
| Target Year | Professional degree students | Target Student | ||
| Language | Japanese | 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 operations and system relied on in carrying out clinical trials, and the roles and areas of responsibility of researchers, research assistants, and test statisticians. * Understand the statistical items to be included in clinical trial protocols and obtain the fundamental knowledge and techniques required to be able to contribute to the creation of clinical trial protocols. * Acquire the fundamental knowledge and skills to be able 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 be capable of contributing 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 (Periods 1-6, 8:45-19:45) Day 1 Period 1: Pre-Training Preparation Period 2: Readiness as a Biostatistician (1) Period 2: Ethics in medical research Period 4: Seed Development Period 5: Statistics Consulting Situations Period 6: Creating Reports Day 2 Period 1: Pre-Training Preparation Period 2: Readiness as a Biostatistician (2) Period 3: Monitoring Tasks Period 4: Clinical Test Sites Period 5: Statistics Consulting Situations Period 6: Creating Reports Day 3 Period 1: Pre-Training Preparation Period 2: Readiness as a Biostatistician (3) Period 3: Project Management Tasks Period 4: The History and Future Potential of Translational Research Period 5: Statistics Consulting Situations Period 6: Creating Reports Day 4 Period 1: Pre-Training Preparation Period 2: Data Management Tasks Period 3: The Role of CRC Period 4: Investigational New Drug Management System Scenarios Period 5: Statistics Consulting Situations Period 6: Creating Reports Day 5 Period 1: Pre-Training Preparation Period 2: Corresponding with Authorities Period 3: Radiodiagnosis Scenarios Period 4: Advanced Medical Technology Scenarios Period 5: Development of Innovative Medical Technologies Using iPS Cells Period 6: Creating Reports National Cerebral and Cardiovascular Center This will be held over a total of six days. The first day will be in August, with the remaining five days held between December and January (Each session is 90 minutes long) (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 Arrhythmia Session 3: Cardiovascular Disease Fundamentals (2): The Basics of Cardiac Failure Session 4: Medical Device Research and Development: Visit to an Animal Experimentation Facility Day 2 Session 5: Clinical Trial Planning (1): Basic Matters of Clinical Trial Planning Session 6: Clinical Trial Planning (2): Basic Procedures in Clinical Trial Planning Session 7: Randomized Assignment (1): The Role of Randomized Assignment in Clinical Trials Session 8: Randomized Assignment (2): General Methods of Randomized Assignment Day 3 Session 9: Group Work: Randomized Assignment System Exercise (1) Session 10: Group Work: Randomized Assignment System Exercise (2) Session 11: Sample Size Design (1): Methods of Sample Size Design in Clinical Trials Session 12: Sample Size Design (1): Procedures for Sample Size Design in Clinical Trials Day 4 Session 13: Group Work: Sample Size Design Exercise (1) Session 14: Group Work: Sample Size Design Exercise (2) Session 15: Statistical Analysis Plans (1): Fundamental Points to Describe in a Statistical Analysis Plans Session 16: Statistical Analysis Plans (2): Standard Tasks and Processes for Statistical Analysis in Clinical Trials Day 5 Session 17: Accompanying CRC Patients Session 18: Accompanying CRC Patients Session 19: Group Work (5): Randomized Assignment System Exercise (3) Session 20: Group Work (6): Randomized Assignment System Exercise (4) Day 6 Session 21: Group Work (7): Sample Size Design Exercise (3) Session 22: Group Work (8): Sample Size Design Exercise (4) Session 23: Summary Presentation (1): Reporting on the Results of the Randomized Assignment System Exercise Session 24: Summary Presentation (2): Report on the Results of the Sample Size Design Exercise |
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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 | None | |||
| Study outside of Class (preparation and review) | Indicated during practicums. | |||
| Textbooks | Textbooks/References | Not used. | ||
| References, etc. | Not used. | |||
