Learning outcomes

The student will have acquired general knowledge about clinical research. 

Goals

The student will have acquired knowledge of the importance of conducting clinical trials in general (the history of clinical trials, why conduct a clinical trial, the importance of clinical trials in Evidence Based Medicine, etc.); the practical conduct of a clinical trial; the main players involved in developing and conducting a clinical trial; the key stages in conducting a clinical trial, including the importance of the clinical trial committee and the role of the clinical trial investigator. ); the practical conduct of a clinical trial; the main players involved in developing and conducting a clinical trial; the key stages in conducting a clinical trial, including the importance of the ethics committee, monitoring adverse events, etc.; the role of regulatory agencies (EMA, FDA), good clinical practice and quality assurance. In addition, students will be trained in systematic bibliographical research, to raise their awareness of this key preliminary stage in the development of a research project.

Content

  • Introduction to clinical research and clinical study designs
  • Important concepts in clinical research: quantitative/qualitative research, data collection methods, inductive/deductive research, research questions/objectives/hypotheses, recruitment methods.
  • Importance of conducting clinical trials in general (history of clinical trials, reasons for conducting a clinical trial, importance of clinical trials in Evidence-Based Medicine, etc.).
  • The role of clinical trials in Belgium.
  • Practical conduct of a clinical trial: introduction to the phases of clinical trials, introduction to clinical trial methodology.
  • Systematic literature search.

Exercices

  • In-class exercises
  • Group work in the form of a debate on a clinical research topic (pro/con) — this group work will require preparation at home as well as an in-class presentation.

Teaching methods

A course book will be provided to students at the beginning of the course; it will include an introduction, the course structure, the educational format, the schedule, the course objectives, the examination modalities, the language of instruction, and the professor’s contact information.


Presentations in the form of PowerPoint slides, with materials made available on Webcampus

In-class exercises

Group work in the form of a debate on a clinical research topic (pro/con) — this group work will require preparation at home as well as an in-class presentation.

Assessment method

QCM written examination + open questions

Sources, references and any support material

  1. Essais Cliniques: Théorie, Pratique et Critique, G Bouvenot & M Vray, 4ème Ed., Médecine-Sciences Flammarion, 2006
  2. Drug Discovery and Development, HP Rang, Churchill-Livingstone Elsevier, 2006; 2nd Ed. Hill & Rang, 2012
  3. Drugs: from discovery to approval, 2nd Ed., Rick Ng, Wiley-Blackwell, 2009; 3rd Ed. June 201
  4. 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

Language of instruction

French
Training Study programme Block Credits Mandatory
Bachelor in Biomedical Sciences Standard 0 2
Bachelor in Biomedical Sciences Standard 3 2