Doctor of Philosophy Program in Clinical Epidemiology (International Program) Master of Science Program in Medical Epidemiology (International Program)
May 25, 2020
Course: RACE 617: Randomized Controlled Trials Credits: 2(1-2-3) Course Coordinator: Assoc.Prof.Dr.Atiporn Ingsathit, Assist.Prof. Dr. Chusak Okascharoen
E-mail: [email protected] Period:
Jun 1st– July 10th, 2020No. Date Time Topic Instructor Room
1 Mon, Jun 1, 2020 09.00 – 12.00 Forming research question and ethical principles for clinical trial
Asst.Prof.Dr.Chusak Okascharoen Zoom 13.00 – 16.00 Self – study: Forming research question and ethical principles for clinical trial
2. Wed, Jun 3, 2019 09.00 – 12.00 Defining & selecting participants, Intervention and Comparison group, outcome assessments
Asst.Prof.Dr.Chusak Okascharoen Zoom 13.00 – 16.00 Self – study: Defining & selecting participants, Intervention and Comparison group, outcome
assessments 3. Mon, Jun 8, 2020 09.00 – 12.00 Randomization, allocation concealment, blinding &
maximizing follow up and reporting
Assoc.Prof.Dr.Atiporn Ingsathit Zoom 13.00 – 16.00 Self – study: Randomization, allocation concealment, blinding & maximizing follow up 4.
Wed, Jun 10, 2020
09.00 – 12.00 Alternative trial design: Factorial, cross-over and cluster design
Assist.Prof.Dr.Chusak Okascharoen Zoom Self – study: Alternative trial design: Factorial, cross-over and cluster design
5. 13.00 – 16.00 Trial management & Organization in large-scale and Multi-center trials
Prof.Punnee Pitisutithum Zoom Self – study: Trial management & Organization in large-scale and Multi-center trials 6. Thu, Jun 11, 2020 09.00 – 12.00 Advance Design in RCT: Non-inferiority and Adaptive
Design
Assist.Prof.Dr.Chusak Okascharoen Zoom 13.00 – 16.00 Self – study: Advance Design in RCT: Non-inferiority and Adaptive Design
7. Mon, Jun 22, 2020 09.00 – 12.00 Conducting Phase I & II Clinical Trial Dr Thanyanan Reungwetwattana Zoom 13.00 – 16.00 Self – study: Conducting Phase I & II Clinical Trial
8. Wed, Jun 24, 2020 09.00 – 12.00 Statistical issues in RCT
Randomization list generation
Dealing with protocol violation: ITT, PPA
Interim analysis: Multiple test correction, stopping rule
Assoc.Prof.Jaranit Kaewkungwal Zoom
13.00 – 16.00 Self – study: Statistical issues in RCT
9. Mon, Jun 29, 2020 09.00 – 12.00 Good Clinical Practice (GCP) and Auditing Prof.Punnee Pitisutithum Zoom 13.00 – 16.00 Self – study: Good Clinical Practice (GCP) and Auditing
10. Thu, Jul 2, 2020 13.00 – 16.00 Real case study of randomized controlled trial Assoc.Prof.Dr.Boonying Siribumrungwong
Zoom Self – study: Trial registration and reporting the result
11. Fri, Jul 10, 2020 24.00 Final Examination: Submission of protocol (40%)
Doctor of Philosophy Program in Clinical Epidemiology (International Program) Master of Science Program in Medical Epidemiology (International Program)
May 25, 2020
Proportion of Evaluation
Pre-class quiz from reading assignment (short answer questions) 20%
Post-class assignments (short answer questions) 20%
