Student will learn that managing clinical trials requires an efficient study management of every single aspect of the study in order to be successful;
Student will receive insights about the role of the Clinical Study Manager (CSM) and will learn that CSM leads all aspects of the study and provides continuous feedback on recruitment, site selection, and how to run each phase, throughout the entire duration of the trial;
Student will be aware that the clinical trial management team proactively monitors study milestones to ensure the study is not only successful, but delivered on time and on budget;
Student will understand the need of a Clinical Trial Management System (CTMS) database, a web-based tool that provides sponsors with access to near real-time data and study metrics, empowering clinical trial managers to deliver powerful solutions throughout the drug development process.
A study succeeds or fails on the basis of whether it manages to recruit the pre-specified number of participants to reliably answer the question. The objective is to understand and gain thorough knowledge on the management of clinical studies and recruitment strategies.
Next to the fundamental course on ‘Clinical Trials’ (MSBM M103), this course puts more emphasis in the practice of the theoretical concepts. The role of clinical study manager will be explained.
Applicable software system used by biotechnology and pharmaceutical industries will be explained as well, with focus on planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
The course we highlight the following topics:
-Efficient recruitment of trial participants,
-The importance of education and experienced study personnel
-Publication of trial results and dissemination
Oral examination
The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.
The Course Clinical Trials s 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/ Essais Cliniques: Théorie, Pratique et Critique, G Bouvenot & M Vray, 4ème Ed., Médecine-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
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences, Professional focus in Clinical Research | Standard | 0 | 3 | |
| Master in Biomedical Sciences, Professional focus in Clinical Research | Standard | 2 | 3 |