Teacher(s)
Language
English
Content
Contents
I. Clinical trials
I.1 Basics & Principles
I.2 Trials methodology
I.3 Clinical Phase I (first-in-man trial)
I.4 Clinical Phase II (first-in-patient trial)
I.5 Clinical Phase III (evidence trial)
II. Survival analysis
II.1 Fundamental concepts
II.2 Survival and hazard
II.3 Kaplan-Meier estimate
II.4 Log-rank test
II.5 Cox regression
II.6 Sample size for a survival study
I. Clinical trials
I.1 Basics & Principles
I.2 Trials methodology
I.3 Clinical Phase I (first-in-man trial)
I.4 Clinical Phase II (first-in-patient trial)
I.5 Clinical Phase III (evidence trial)
II. Survival analysis
II.1 Fundamental concepts
II.2 Survival and hazard
II.3 Kaplan-Meier estimate
II.4 Log-rank test
II.5 Cox regression
II.6 Sample size for a survival study
Teaching methods
Learning will take place
· through face-to-face lectures illustrated with real-life examples
· through practical exercises.
· through face-to-face lectures illustrated with real-life examples
· through practical exercises.
Evaluation methods
A two-part written examination: one part covering theoretical questions relating to the concepts covered in the course, and the other consisting of practical exercises using statistical software, as practised during the practical sessions.
Decimals will be rounded down to the nearest whole number.
AI may be used as a revision aid and support tool, but is not permitted during the final assessment.
Decimals will be rounded down to the nearest whole number.
AI may be used as a revision aid and support tool, but is not permitted during the final assessment.
Online resources
The course slides and reference materials are available on Moodle
Bibliography
Eric Vittinghoff • David V. Glidden • Stephen C. Shiboski • Charles E. McCulloch. Regression Methods in Biostatistics. Linear, Logistic, Survival, and Repeated Measures Models. Springer, 2012 (2nd Edition) (Pages 54-62)
Zeng M, Mao XH, Li JX, Tong WD, Wang B, Zhang YJ, Guo G, Zhao ZJ, Li L, Wu DL, Lu DS, Tan ZM, Liang HY, Wu C, Li DH, Luo P, Zeng H, Zhang WJ, Zhang JY, Guo BT, Zhu FC, Zou QM. Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Oct 10;386(10002):1457-64. doi: 10.1016/S0140-6736(15)60310-5. Epub 2015 Jun 30. PMID: 26142048.
Zeng M, Mao XH, Li JX, Tong WD, Wang B, Zhang YJ, Guo G, Zhao ZJ, Li L, Wu DL, Lu DS, Tan ZM, Liang HY, Wu C, Li DH, Luo P, Zeng H, Zhang WJ, Zhang JY, Guo BT, Zhu FC, Zou QM. Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Oct 10;386(10002):1457-64. doi: 10.1016/S0140-6736(15)60310-5. Epub 2015 Jun 30. PMID: 26142048.
Teaching materials
- support disponible sur Moodle
Faculty or entity