Hiroshima University Syllabus

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Academic Year 2024Year School/Graduate School Graduate School of Biomedical and Health Sciences (Master’s Course)
Lecture Code TB011203 Subject Classification Specialized Education
Subject Name 臨床研究方法論
Subject Name
Subject Name in
Basic and Advanced Training on Methodology for Clinical Research
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,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
Lecture 1-12, face-to-face class (For students who can' t attend face-to-face, a video of the class is uploaded to moodle. If you are taking the course from moodle, please make sure to take the course and submit your assignment by the deadline stated in moodle. Those who have not submitted their assignments are considered absent.)

Lecture 13-15, group work (face-to-face or online:teams) No on-demand. If student cannot attend, contact to Dr. Akita.  
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
(Applicable only to targeted subjects for undergraduate students)
Criterion referenced
(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) Practice in Data analysis (Tomoyuki Akita)(face-to-face)
Lesson 5 (11/5) Topics in Epidemiology & Biostatistics (Tomoyuki Akita)(face-to-face)
Lesson 6 (11/12) Medical research and drug development (Yoichi Kohno)(face-to-face) 
Lesson 7 (11/19) Basic observational study (Shingo Fukuma)(face-to-face)
Lesson 8 (12/26) Designing Clinical Research Project (Shingo Fukuma)(face-to-face)
Lesson 9 (12/3) Basic clinical trials (Masako Nishikawa)(on-demand) 
Lesson 10 (12/10) Planning of clinical trials I (Masako Nishikawa)(on-demand)
Lesson 11 (12/17) Planning of clinical trials Ⅱ (Tomoyuki Akita/Shingo Fukuma)(face-to-face)
Lesson 12 (1/7) Topic in clinical research (Shingo Fukuma/Tomoyuki Akita)(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.  
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
(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
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.

Completing or taking the course "Exercises and Seminar on Medical Statistics Using Statistical Software (3T)" is recomended.  
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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