Detail mata kuliah Uji Klinik (Clinical Trial), program studi S2 - Epidemiologi

Detail SAP: Uji Klinik (Clinical Trial) Tahun Ajaran 2017/2018 -01


Satuan Acara Pengajaran
Mata Kuliah PHE2804033 - Uji Klinik (Clinical Trial)
Pengajar dr. Lhuri Dwianti Rahmartani B.Med.Sc., M.Epid.
Prof. dr. Asri C. Adisasmita MPH., M.Phil., Ph.D
Tujuan Perkuliahan

Minggu Ke 1
Materi Introduksi mata ajaran Introduction to Clinical Trial
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 2
Materi Basic Design Consideration
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 3
Materi Study Design: - Phase I trial - Phase II trial - Phase III trial
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 4
Materi Study Design II: - Cross-over design - Factoral design - Large and simple trial - Active Control trial
Media LCD
Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 5
Materi Superiority VS Equivalence VS Non-Inferiority Trials I
Media LCD
Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 6
Materi Superiority vs Equivalence vs Non-Inferiority Trials II Assignment I (Study Design)
Media LCD
Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 7
Materi Presentation of Assignment I Sample size and Recruitment of Study Participants
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Presentasi, diskusi dan kuliah

 

Minggu Ke 8
Materi Ujian Tengah Semester (UTS)
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Referensi
Aktivitas

 

Minggu Ke 9
Materi Bias related issues in Clinical Trial I: - randomization - Blinding - Concealment
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 10
Materi Bias related issues in Clinical Trial II: - Lost to follow-up - Monitoring-Stopping - Interim Analysis
Media LCD
Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 11
Materi Bias related issues Clinical Trial III: - Intention To Treat Analysis - Per Protocol Analysis - As Treated Analysis Assignment II (Biases)
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 12
Materi Presentation of assignment II
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Presentasi, kuliah dan diskusi

 

Minggu Ke 13
Materi Quantifying Treatment Effect
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 14
Materi Quantifying Treatment Effect - Cost Effectiveness Analysis Assignment III (Treatment Effect)
Media LCD
Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Kuliah dan diskusi

 

Minggu Ke 15
Materi Presentation of Assignment III Critical Appraisal of Clinical Trial
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Referensi 1. Design and Analysis of Clinical trials. Chow S and Liu J. 2004. 2. Fundamentals of Clinical Trials. Friedman LM, DeMets DL, Furberg CD. 1996. 3. Design of Studies for Medical Research. Machin D and Campbell MJ. 2005. 4. Cinical Trials. Pocock. 1983. 5. Artikel-artikel dan hand-ouut. 6. Cinical Epidemiology. The Essentials. Fletcher RW and Fletcher SW. 2005. 7. Critical Appraisal of Epidemiological Studies and Clinical Trials. (2nd atau 3 rd ed). Elwood.
Aktivitas Presentasi, diskusi dan kuliah

 

Minggu Ke 16
Materi Ujian Akhir Semester (UAS)
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Referensi
Aktivitas