2021-2022 / SBIM2012-1

Biomarkers and surrogate markers in clinical research

Duration

25h Th, 10h Pr

Number of credits

 Master in biomedicine (120 ECTS)3 crédits 

Lecturer

Dominique de Seny

Language(s) of instruction

English language

Organisation and examination

Teaching in the second semester

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Recent advances in clinical research and multi-OMICs techniques have led to the discovery of a large number of biomarkers. These biomarkers are of major interest for the development of personalized medicine. They are indicators of disease progression, physiological changes or response to treatment. They represent therefore a strategic perspective for new drug development by pharmaceutical industries. However, the path from discovery to full validation of each biomarker remains long, expensive and selective. Only few companion disease markers have so far been approved by federal agencies such as the US Food and Drug Administration (FDA). As a result, some biomarkers remain only described through scientific communications and publications while they never reach their official approval. Nevertheless, they can still be used as biological, pathogenic or treatment response indicators.
This course will provide several tools to learn about the development of robust biomarkers from discovery to validation and to be critical about biomarkers highlighted in the literature.

Learning outcomes of the learning unit

The purposes of this course will be to define the concept of a biomarker and of parameters assessing the validity of a marker as a clinical indicator for the presence or absence of a disease. We will discuss the main recommendations for biomarker evaluation as well as diagnostic performance indices and ROC curves. From multi-OMIC approaches, we will determine the methodology needed to go from the discovery to clinical validation of biomarkers. We will also determine how to quantify the added value of a biomarker or how to integrate biomarkers into a diagnostic approach. These theoretical notions will be illustrated by the description of different biomarkers used in clinical diagnosis or therapeutic efficacy. Finally, we will also determine how to analyze biomarkers highlighted in the literature and what criteria to use to determine the robustness of a potential marker.

Prerequisite knowledge and skills

The student must have basic knowledge in statistics as well as in biochemistry concerning the genome, epigenome, transcriptome, proteome and microbiome.

Planned learning activities and teaching methods

This lecture will be supported by powerpoint slides illustrating theoretical aspects of biomarkers from their discovery to validation. Examples of biomarkers currently used in clinical biology will make these theoretical notions more concrete.
Journal club: Interactive discussion based on scientific publications will be encouraged through journal club session. A collective analysis of the same article will be first detailed with all students. Then the analysis of several publications illustrating the same topic through different approaches will be confronted by different groups of students.
Practical work: An interactive seminar prepared by each student on a biomarker extracted from the literature will enable the student to demonstrate that the biomarker meets criteria as described by STARDs (STAndards for Reporting of Diagnostic Accuracy).

Mode of delivery (face to face, distance learning, hybrid learning)

The course will be given in English as a face-to-face lecture (Codes Green / Yellow / Orange)
If lockdown (Red Code): Distance-learning

Recommended or required readings

Assessment methods and criteria

Students competence will be evaluated by passing a written examination on theoretical aspects of biomarkers but also on summary discussions made in class about scientific publications.
Students will also be evaluated on the oral presentation based on given biomarker during the practical work.
Codes Green / Yellow / Orange
The exam will cover the entire lecture given in face-to-face
Code Red
The exam will cover the entire lecture given in face-to-face and / or video-conference
 

Work placement(s)

Organizational remarks

The use of a laptop in class will be recommended for bibliographic research and learning on search engines.

Contacts

Dominique de Seny
ddeseny@uliege.be