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) |
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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 |
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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 |
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Special Subject |
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Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students) | |
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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)(face-to-face) 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. |
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(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 |
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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 |
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Summary of Practical Experience and Class Contents based on it |
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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. |