BIOMARKERS AND SURROGATE MARKERS IN CLINICAL DERMATOLOGY TRIALS
Guest speakers (12 h - 2 ECTS)
Theory: 12 h
| Title | Biomarkers and surrogate markers in clinical dermatology trials (2 ECTS) |
| Program
|
Students will be able to discriminate a biomarker from a surrogate marker in the context of regulatory affairs and their importance in the interpretation of clinical trials in dermatology. |
| Sources | The Course is based upon the following books:
1/ Fundamentals of Clinical Trials, LM Friedman, CD Furberg, DL DeMets, 4th Ed., Springer, 2010; (5th Ed. in November 2015) 2/ Clinical Trials. G Bouvenot & M Vray, 4th Ed., Medicine-Sciences Flammarion, 2006 3/ Drug Discovery and Development, HP Rang, Churchill-Livingstone Elsevier, 2006; 2nd Ed. Hill & Rang, 2012 4/ Drugs: from discovery to approval, 2nd Ed., Rick Ng, Wiley-Blackwell, 2009; 3rd Ed. June 2015 5/ Trouet C, Gobert M, Podoor M. Clinical Trials in Belgium. (The Belgian implementation of the European Clinical Trials Directives. An operational guidance). 2de Ed. (2007), Intersentia |
| Objectives and expected results | To understand what are biomarkers and surrogate markers in dermatology, their importance in the context of regulatory affairs, and their value in the interpretation of clinical trials. |
| Prerequisites | Bachelor degree in sciences
|
| Teaching methods | Interactive seminars given by clinicians and regulatory affairs experts |
| Exam modality | Oral presentation and discussion of the analysis of a research article in the field. |
TITLE
Biomarkers and surrogate markers in clinical dermatology trials (2 ECTS)
PROGRAM
Students will be able to discriminate a biomarker from a surrogate marker in the context of regulatory affairs and their importance in the interpretation of clinical trials in dermatology.
SOURCES
The Course is based upon the following books:
1/ Fundamentals of Clinical Trials, LM Friedman, CD Furberg, DL DeMets, 4th Ed., Springer, 2010; (5th Ed. in November 2015)
2/ Clinical Trials. G Bouvenot & M Vray, 4th Ed., Medicine-Sciences Flammarion, 2006
3/ Drug Discovery and Development, HP Rang, Churchill-Livingstone Elsevier, 2006; 2nd Ed. Hill & Rang, 2012
4/ Drugs: from discovery to approval, 2nd Ed., Rick Ng, Wiley-Blackwell, 2009; 3rd Ed. June 2015
5/ Trouet C, Gobert M, Podoor M. Clinical Trials in Belgium. (The Belgian implementation of the European Clinical Trials Directives. An operational guidance). 2de Ed. (2007), Intersentia
OBJECTIVES AND EXPECTED RESULTS
To understand what are biomarkers and surrogate markers in dermatology, their importance in the context of regulatory affairs, and their value in the interpretation of clinical trials.
PREREQUISITES
Bachelor degree in sciences.
TEACHING METHODS
Interactive seminars given by clinicians and regulatory affairs experts
EXAM MODALITY
Oral presentation and discussion of the analysis of a research article in the field.
Last modified: April 29, 2021