TB910003 Basic and Advanced Training on Methodology for Clinical Research

Hiroshima University Syllabus

Japanese

Academic Year 2025Year School/Graduate School Graduate School of Biomedical and Health Sciences (Doctoral Course)

Lecture Code TB910003 Subject Classification Specialized Education

Subject Name 臨床研究の基礎および実践

Subject Name
（Katakana）リンショウケンキュウノキソオヨビジッセン

Subject Name in
English Basic and Advanced Training on Methodology for Clinical Research

Instructor FUKUMA SHINGO,TAGURI MASATAKA,TSUTSUMI YUSUKE,KONO YOICHI,KO KO,IMADA HIROHITO,AKITA TOMOYUKI,TATSUKAWA YUMIKO,SUGIYAMA AYA

Instructor
(Katakana) フクマ　シンゴ,タグリ　マサタカ,ツツミ　ユウスケ,コウノ　ヨウイチ,コ　コ,イマダ　ヒロヒト,アキタ　トモユキ,タツカワ　ユミコ,スギヤマ　アヤ

Campus Kasumi Semester/Term 1st-Year,  Second Semester,  Second Semester

Days, Periods, and Classrooms (2nd) Tues13-14：MED Rm 2

Lesson Style Seminar Lesson Style
(More Details) Face-to-face

Seminar, Practice
In principle, Lecture 1-12 will be conducted face-to-face.
Lecture 13-15, group work (face-to-face)

Credits 2.0 Class Hours/Week 2 Language of Instruction B : Japanese／English

Course Level 6 : Graduate Advanced

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 01 : Medical Sciences

Eligible Students Master's course students, Doctoral course

Keywords SDG_03

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students) MPH program: "Epidemiology" in Council on Education for Public Health (CEPH) USA
Criterion referenced
Evaluation
(Applicable only to targeted subjects for undergraduate students)

Class Objectives
/Class Outline Understand the research design of clinical studies (including epidemiological studies and clinical trials) through the research planning process.

Class Schedule Lesson 1  Basic biostatistics I  (Tomoyuki Akita)（face-to-face）
Lesson 2 Basic biostatistics II (Tomoyuki Akita)（face-to-face）
Lesson 3  Basic biostatistics III (Tomoyuki Akita)（face-to-face）　
Lesson 4   Practice in Data analysis（Tomoyuki Akita）（Face-to-face）
Lesson 5 Medical research and drug development (Yoichi Kohno)（face-to-face）　
Lesson 6 Basic clinical trials (Tomoyuki Akita)（on-demand）
Lesson 7 Designing Clinical Research Project (Shingo Fukuma)（face-to-face）
Lesson 8 How research change my life (Ysuke Tsutsumi)（face-to-face）
Lesson 9  Propensity Score Methods in Clinical Research (Masataka Taguri)（face-to-face）
Lesson 10 Planning of clinical trials I (Tomoyuki Akita)（face-to-face）
Lesson 11 Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face）　
Lesson 12  Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face）
Lesson 13 Practice in protocol of clinical trial and epidemiological study (creating outline of protocol), Part 1(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams）
Lesson 14) Practice in protocol of clinical trial and epidemiological study (reviewing other group's protocol), Part 2(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams）
Lesson 15 Presentation of protocol of clinical trial and epidemiological study (Presentation of protocol and question and answer)(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams）

3 times reports and final presentation

Order of lecture may be changed.

Text/Reference
Books,etc. Handout,
Shunichi Fukuhara: On the Road to Clinical Research　Research Design in Seven Steps, iHope
Michael Harris & Gordon Taylor. Medical Statistics Made Easy. Scion Pub Ltd
Aviva Petrie & Caroline Sabin. Medical statistics at a glance. Wiley-Blackwell

PC or AV used in
Class,etc. Handouts, Visual Materials, Microsoft Teams, Microsoft Forms, Other (see [More Details]), moodle

(More Details) Lecture 1-4: Lecture using Slide and practice of JMP
Lecture 5-12: Lecture using Slide
Lecture 13-15: Group work

Learning techniques to be incorporated Discussions, Paired Reading, Quizzes/ Quiz format, PBL (Problem-based Learning)/ TBL (Team-based Learning), Project Learning, Post-class Report

Suggestions on
Preparation and
Review Please have motivation and attend the course.
Make sure to confirm the understanding of the lecture content through quiz (Forms) after each class. Also, feel free to ask questions within the Form, and make good use of it.

Lesson 1 to 4  will consist of practical exercises in data analysis using the statistical software JMP. I will be circulating among desks, so please ask if you have any doubts. Analyzing your own data using the methods learned in class will serve as a review after the lecture.
Lesson 5 to 12 will primarily focus on reviewing lecture content related to medical research and clinical trials. Additionally, please consider your research topic and prepare to discuss the protocol to be presented in the final session.
Lesson 13 to 15 will involve practical exercises in protocol development. However, creating protocols and conducting mutual reviews will require work outside of class time.

Requirements Students must be able to attend the 13th~15th classes in real time to enroll in the course.
Bring your PC.
Statistical soft is to be JMP student edition. Please install it before starting the lecture
Last report is the application form of clinical trial or epidemiological study.
Please think about your theme.
https://cimr.hiroshima-u.ac.jp/rinsho/jmp
Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recommended.

Grading Method Attitude to Lecture,
Quiz after every lecture, 3 Reports(medical statistics, research plan)
In the case of on-demand courses, please note that attendance may not be considered if there are extremely few comments on the quiz, or if it is unclear from the content of the comments whether the student is attending the video or not.

Practical Experience

Summary of Practical Experience and Class Contents based on it

Message Basic exercises of Biostatistics (medical statistics).
Learn the basic terminology and clinical method used in clinical trials.

Other Language
Handout of all lecture: Japanese and English (Both)
Explanation by lecturer: Lecture 5 (Japanese), Lecture 7,8, 9(English), Lecture 1,2,3,4,6,10,11,12 (Japanese and English), Lecture 13-15 (Group work and presentation by student, therefore depend on student)

Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching.

Academic Year	2025Year	School/Graduate School	Graduate School of Biomedical and Health Sciences (Doctoral Course)
Lecture Code	TB910003	Subject Classification	Specialized Education
Subject Name	臨床研究の基礎および実践
Subject Name （Katakana）	リンショウケンキュウノキソオヨビジッセン
Subject Name in English	Basic and Advanced Training on Methodology for Clinical Research
Instructor	FUKUMA SHINGO,TAGURI MASATAKA,TSUTSUMI YUSUKE,KONO YOICHI,KO KO,IMADA HIROHITO,AKITA TOMOYUKI,TATSUKAWA YUMIKO,SUGIYAMA AYA
Instructor (Katakana)	フクマ　シンゴ,タグリ　マサタカ,ツツミ　ユウスケ,コウノ　ヨウイチ,コ　コ,イマダ　ヒロヒト,アキタ　トモユキ,タツカワ　ユミコ,スギヤマ　アヤ
Campus	Kasumi	Semester/Term	1st-Year, Second Semester, Second Semester
Days, Periods, and Classrooms	(2nd) Tues13-14：MED Rm 2
Lesson Style	Seminar	Lesson Style (More Details)	Face-to-face
Seminar, Practice In principle, Lecture 1-12 will be conducted face-to-face. Lecture 13-15, group work (face-to-face)
Credits	2.0	Class Hours/Week	2	Language of Instruction	B : Japanese／English
Course Level	6 : Graduate Advanced
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	01 : Medical Sciences
Eligible Students	Master's course students, Doctoral course
Keywords	SDG_03
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)	MPH program: "Epidemiology" in Council on Education for Public Health (CEPH) USA
Criterion referenced Evaluation (Applicable only to targeted subjects for undergraduate students)
Class Objectives /Class Outline	Understand the research design of clinical studies (including epidemiological studies and clinical trials) through the research planning process.
Class Schedule	Lesson 1 Basic biostatistics I (Tomoyuki Akita)（face-to-face） Lesson 2 Basic biostatistics II (Tomoyuki Akita)（face-to-face） Lesson 3 Basic biostatistics III (Tomoyuki Akita)（face-to-face）　 Lesson 4 Practice in Data analysis（Tomoyuki Akita）（Face-to-face） Lesson 5 Medical research and drug development (Yoichi Kohno)（face-to-face）　 Lesson 6 Basic clinical trials (Tomoyuki Akita)（on-demand） Lesson 7 Designing Clinical Research Project (Shingo Fukuma)（face-to-face） Lesson 8 How research change my life (Ysuke Tsutsumi)（face-to-face） Lesson 9 Propensity Score Methods in Clinical Research (Masataka Taguri)（face-to-face） Lesson 10 Planning of clinical trials I (Tomoyuki Akita)（face-to-face） Lesson 11 Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face）　 Lesson 12 Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face） Lesson 13 Practice in protocol of clinical trial and epidemiological study (creating outline of protocol), Part 1(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams） Lesson 14) Practice in protocol of clinical trial and epidemiological study (reviewing other group's protocol), Part 2(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams） Lesson 15 Presentation of protocol of clinical trial and epidemiological study (Presentation of protocol and question and answer)(Aya Sugiyama/ Ko Ko/Yumiko Tatsukawa/Hirohito Imada/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams） 3 times reports and final presentation Order of lecture may be changed.
Text/Reference Books,etc.	Handout, Shunichi Fukuhara: On the Road to Clinical Research　Research Design in Seven Steps, iHope Michael Harris & Gordon Taylor. Medical Statistics Made Easy. Scion Pub Ltd Aviva Petrie & Caroline Sabin. Medical statistics at a glance. Wiley-Blackwell
PC or AV used in Class,etc.	Handouts, Visual Materials, Microsoft Teams, Microsoft Forms, Other (see [More Details]), moodle
(More Details)	Lecture 1-4: Lecture using Slide and practice of JMP Lecture 5-12: Lecture using Slide Lecture 13-15: Group work
Learning techniques to be incorporated	Discussions, Paired Reading, Quizzes/ Quiz format, PBL (Problem-based Learning)/ TBL (Team-based Learning), Project Learning, Post-class Report
Suggestions on Preparation and Review	Please have motivation and attend the course. Make sure to confirm the understanding of the lecture content through quiz (Forms) after each class. Also, feel free to ask questions within the Form, and make good use of it. Lesson 1 to 4 will consist of practical exercises in data analysis using the statistical software JMP. I will be circulating among desks, so please ask if you have any doubts. Analyzing your own data using the methods learned in class will serve as a review after the lecture. Lesson 5 to 12 will primarily focus on reviewing lecture content related to medical research and clinical trials. Additionally, please consider your research topic and prepare to discuss the protocol to be presented in the final session. Lesson 13 to 15 will involve practical exercises in protocol development. However, creating protocols and conducting mutual reviews will require work outside of class time.
Requirements	Students must be able to attend the 13th~15th classes in real time to enroll in the course. Bring your PC. Statistical soft is to be JMP student edition. Please install it before starting the lecture Last report is the application form of clinical trial or epidemiological study. Please think about your theme. https://cimr.hiroshima-u.ac.jp/rinsho/jmp Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recommended.
Grading Method	Attitude to Lecture, Quiz after every lecture, 3 Reports(medical statistics, research plan) In the case of on-demand courses, please note that attendance may not be considered if there are extremely few comments on the quiz, or if it is unclear from the content of the comments whether the student is attending the video or not.
Practical Experience
Summary of Practical Experience and Class Contents based on it
Message	Basic exercises of Biostatistics (medical statistics). Learn the basic terminology and clinical method used in clinical trials.
Other	Language Handout of all lecture: Japanese and English (Both) Explanation by lecturer: Lecture 5 (Japanese), Lecture 7,8, 9(English), Lecture 1,2,3,4,6,10,11,12 (Japanese and English), Lecture 13-15 (Group work and presentation by student, therefore depend on student)
Please fill in the class improvement questionnaire which is carried out on all classes. Instructors will reflect on your feedback and utilize the information for improving their teaching.

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