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