TB910003 Basic and Advanced Training on Methodology for Clinical Research

Hiroshima University Syllabus

Japanese

Academic Year 2024Year 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,NISHIKAWA MASAKO,KONO YOICHI,KO KO,AKITA TOMOYUKI,TATSUKAWA YUMIKO,SUGIYAMA AYA

Instructor
(Katakana) フクマ　シンゴ,ニシカワ　マサコ,コウノ　ヨウイチ,コ　コ,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) 　

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

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

Course Level 5 : Graduate Basic

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 01 : Medical Sciences

Eligible Students Master's course students

Keywords SDG_03

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students)
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 (10/8) Basic biostatistics I  (Tomoyuki Akita)（face-to-face）
Lesson 2 (10/15) Basic biostatistics II (Tomoyuki Akita)（face-to-face）
Lesson 3 (10/22) Basic biostatistics III (Tomoyuki Akita)（face-to-face）　
Lesson 4 (10/29) Medical research and drug development (Yoichi Kohno)（face-to-face）　
Lesson 5 (11/5) Clinical Epidemiology Research (Ysuke Tsutsumi)（face-to-face）
Lesson 6 (11/12)  Practice in Data analysis（Tomoyuki Akita）（Face-to-face）
Lesson 7 (11/19) Basic clinical trials (Masako Nishikawa)（on-demand）
Lesson 8 (11/26) Planning of clinical trials I (Masako Nishikawa)（face-to-face）
Lesson 9 (12/3) Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face）　
Lesson 10 (12/10) Advanced Observational Research (Masataka Taguri)（face-to-face）
Lesson 11 (12/17)  Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face）
Lesson 12 (1/7) Designing Clinical Research Project (Shingo Fukuma)（face-to-face）
Lesson 13 (1/14) Practice in protocol of clinical trial and epidemiological study (creating outline of protocol), Part 1(Aya Sugiyama/ Ko Ko/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams）
Lesson 14 (1/21) Practice in protocol of clinical trial and epidemiological study (reviewing other group's protocol), Part 2(Aya Sugiyama/ Ko Ko/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams）
Lesson 15 (1/28) Presentation of protocol of clinical trial and epidemiological study (Presentation of protocol and question and answer)(Aya Sugiyama/ Ko Ko/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. 　

(More Details) Lecture 1-5: Lecture using Slide and practice of JMP
Lecture 6-12: Lecture using Slide
Lecture 13-15: Group work

Learning techniques to be incorporated 　

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 5  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 6 to 12 will primarily focus on reviewing lecture content related to medical research and clinical trials. Additionally, based on the lecture in Lesson 8, 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 Bring your PC.
Statistical soft is to be JMP(licensed in HU).
Last report is the application form of clinical trial or epidemiological study.
Please think about your theme.
Before starting the lecture, please visit the following website, and submit application form of JMP (campus license) and get
it.
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, echics, research plan)

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 6 (Japanese), Lecture 6,8,9,10(English), Lecture 1,2,3,4,5,11,12 (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	2024Year	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,NISHIKAWA MASAKO,KONO YOICHI,KO KO,AKITA TOMOYUKI,TATSUKAWA YUMIKO,SUGIYAMA AYA
Instructor (Katakana)	フクマ　シンゴ,ニシカワ　マサコ,コウノ　ヨウイチ,コ　コ,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)
Seminar, Practice In principle, Lecture 1-12 will be conducted face-to-face. Lecture 13-15, group work (face-to-face or online:teams)
Credits	2.0	Class Hours/Week		Language of Instruction	B : Japanese／English
Course Level	5 : Graduate Basic
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	01 : Medical Sciences
Eligible Students	Master's course students
Keywords	SDG_03
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)
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 (10/8) Basic biostatistics I (Tomoyuki Akita)（face-to-face） Lesson 2 (10/15) Basic biostatistics II (Tomoyuki Akita)（face-to-face） Lesson 3 (10/22) Basic biostatistics III (Tomoyuki Akita)（face-to-face）　 Lesson 4 (10/29) Medical research and drug development (Yoichi Kohno)（face-to-face）　 Lesson 5 (11/5) Clinical Epidemiology Research (Ysuke Tsutsumi)（face-to-face） Lesson 6 (11/12) Practice in Data analysis（Tomoyuki Akita）（Face-to-face） Lesson 7 (11/19) Basic clinical trials (Masako Nishikawa)（on-demand） Lesson 8 (11/26) Planning of clinical trials I (Masako Nishikawa)（face-to-face） Lesson 9 (12/3) Planning of clinical trials Ⅱ (Tomoyuki Akita)（face-to-face）　 Lesson 10 (12/10) Advanced Observational Research (Masataka Taguri)（face-to-face） Lesson 11 (12/17) Topics in Epidemiology & Biostatistics (Tomoyuki Akita)（face-to-face） Lesson 12 (1/7) Designing Clinical Research Project (Shingo Fukuma)（face-to-face） Lesson 13 (1/14) Practice in protocol of clinical trial and epidemiological study (creating outline of protocol), Part 1(Aya Sugiyama/ Ko Ko/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams） Lesson 14 (1/21) Practice in protocol of clinical trial and epidemiological study (reviewing other group's protocol), Part 2(Aya Sugiyama/ Ko Ko/Tomoyuki Akita/Shingo Fukuma)（face-to-face or Teams） Lesson 15 (1/28) Presentation of protocol of clinical trial and epidemiological study (Presentation of protocol and question and answer)(Aya Sugiyama/ Ko Ko/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.
(More Details)	Lecture 1-5: Lecture using Slide and practice of JMP Lecture 6-12: Lecture using Slide Lecture 13-15: Group work
Learning techniques to be incorporated
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 5 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 6 to 12 will primarily focus on reviewing lecture content related to medical research and clinical trials. Additionally, based on the lecture in Lesson 8, 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	Bring your PC. Statistical soft is to be JMP(licensed in HU). Last report is the application form of clinical trial or epidemiological study. Please think about your theme. Before starting the lecture, please visit the following website, and submit application form of JMP (campus license) and get it. 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, echics, research plan)
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 6 (Japanese), Lecture 6,8,9,10(English), Lecture 1,2,3,4,5,11,12 (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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