Numbering Code	P-PUB01 8H112 LB90	Year/Term	2022 ・ First semester
Number of Credits	2	Course Type	Lecture
Target Year	Professional degree students	Target Student
Language	Japanese and English	Day/Period	Wed.5
Instructor name	TANAKA SHIROU (Graduate School of Medicine Program-Specific Professor) FURUKAWA TOSHIAKI (Graduate School of Medicine Professor) NISHIYAMA CHIKA (Graduate School of Medicine Associate Professor) TERAMUKAI SATOSHI (Part-time Lecturer) SAITO AKIKO (Part-time Lecturer) Omiya Masatomo (Graduate School of Medicine Program-Specific Assistant Professor)
Outline and Purpose of the Course	This course consists of lectures on methodology of clinical trials in accordance with Chapter 3, 5, 6, 9, 10 and 12 to 15 of “Clinical Trials: A Practical Approach”. In addition, 3 lecturers who experienced in investigator-initiated clinical trials in cardiovascular disease, cancer, and translational research areas provide lectures on the practical aspects of clinical trials based on their experience. This course also includes a workshop of developing study protocols of hypothetical clinical trials with small-sized groups. MCR required, CB required, MPH elective.
Course Goals	To understand methodology of clinical trials To understand contents of study protocol and learn how to develop a study protocol through a workshop of protocol development
Schedule and Contents	This class is a hybrid of homework and lecture/workshop sessions. The first session is a face-to-face lecture at Seminar Room on the ground floor of Science Frontier Laboratory. Homeworks are provided using an online system KoALA (https://koala.highedu.kyoto-u.ac.jp). April 14 Introduction (Tanaka) April 21 Creating Evidence for Depression Care: meta-analysis and mega-trials (Furukawa) April 28 Organization and Planning (Tanaka) May 12 Experience in Education Intervention Trials in Cardiovascular Disease (Nishiyama) May 19 Endpoints, Randomization and Blinding (Tanaka) May 26 Statistical Consideration in Protocol Development (Teramukai) June 2 Multiplicity in Hypothesis Tests, Interim Analysis and Monitoring June 9 Issues in Conducting Cancer Clinical Trials and Their Solutions (Saito) June 16 Protocol Deviation, Non-inferiority Trial (Tanaka) June 23 Workshop (protocol development, Tanaka, Imai, Yada) June 30 Workshop (protocol development, Tanaka, Imai, Yada) July 7 Workshop (protocol development, Tanaka, Imai, Yada) July 14 Workshop (protocol development, Tanaka, Imai, Yada) July 21 Workshop (presentation, Furukawa, Nishiyama, Tanaka, Imai, Yada)
Evaluation Methods and Policy	Attendance 50%, Report 50%
Course Requirements	None
Study outside of Class (preparation and review)	Please read the textbook "Clinical Trials: A Practical Approach".
Textbooks	Textbooks/References	Clinical Trials: A Practical Approach, Stuart J. Pocock, (Wiley) A copy of the textbook will be provided.