Course title<English>

EBM研究概論
Studies for Evidence-based Medicine

Kyoto University Hospital
Program-Specific Professor,UESHIMA KENJI
Graduate School of Medicine
Professor,SATO TOSIYA
AffiliatedKyoto University Hospital
department,
Project
Associate Professor,SATOU KEIKO
Job title,Name
Kyoto University Hospital
Program-Specific Assistant Professor,YASUNO SHINJI
奈良県立医科大学 病院教授
KASAHARA MASATO

Target year Professional degree students Number of credits 2
Day/period Mon.2

Class style

Course offeredyear/period

Lecture2017/Second semester

Language Japanese and English[Outline and Purpose of the Course]
I. Course Description
It is an important mission for healthcare researchers to explore standard therapies and evaluations for new
therapies in clinical medicine. For that purpose, we have to conduct clinical trials along with appropriate
methodologies, and accumulate clinical evidences step by step. In order to propel proper clinical trials, theEBM Research Center was established in 2001 at Kyoto University. This EBM Research Center wasreorganized in 2013 into the Department of EBM Research, Institute for Advancement of Clinical andTranslational Science. We have been engaged in conduct and management of various clinical trials, andestablishing infrastructures for clinical research.
In this course, we explain development plans for research questions arouse from clinicians and data
management systems including researcher ethics and use of standard operating procedures. Based on clinical
trials in our department, students will learn about actual practices and difficulties in the design and conduct ofclinical trials.

[Course Goals]
II. Goals and Objectives of the Cours
Understand study concepts for EBM
Understand researcher ethics of clinical trials
Understand basic knowledge of clinical trial and related area
Understand basic issues and solutions of problems of the clinical trial

III. Methods of Instruction
Lecture with Power Point Presentation with Small Group Discussions[Course Schedule and Contents]
October 5What is EBM?
October 19Necessity of large scale clinical trials
October 26History of clinical trials and drug disasterNovember 2Study requirement of clinical research for human person
November 9Arrangement and planning for clinical trials
November 16Understanding clinical trials: treatment allocation
November 30Understanding clinical trials: endpoints
Continue to EBM研究概論(2)↓↓↓

EBM研究概論(2)
December 7Understanding clinical trials: events and safety evaluations
December 14Understanding clinical trials: trials for hypertension
December 21Understanding clinical trials: trials for chronic kidney diseases
December 28Reconsiderations of clinical guidelines
January 4Point of clinical research and epidemiologic research
January 18Task of future clinical trials
January 25Evidence: make, use, and inform
UndecidedCritical exploration for literature
February 11Report Deadline[Class requirement]
None[Method, Point of view, and Attainment levels of Evaluation]
V. Evaluation
Final Report[Textbook]
Instructed during class[Reference books, etc.]（Reference books）
Introduced during class[Regarding studies out of class (preparation and review)]
VI. Prerequisites
There are no pre-requisites for this course.
（Others (office hour, etc.) ）*Please visit KULASIS to find out about office hours.