Clinical Trials
- UE code MSBMM103
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Schedule
24 30Quarter 1
- ECTS Credits 6
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Language
English
- Teacher Beaudart Charlotte
Allowing students to explore fundamental concepts related to clinical trials while maintaining a broad and interdisciplinary approach to clinical trials beyond pure pharmacological studies, enabling the application of these concepts across various fields and disciplines. The course will be designed to equip students with enough knowledge to foster a critical mindset towards the methodologies employed in clinical trials
Methodology of clinical trials; development of a clinical trial protocol ; systematic literature search ; Type of clinical trials (i.e. cross-over studies; equivalence and non-inferiority trials, pragmatic trials, open-single blind, double blind, triple blind trials); real world therapeutic effectiveness, pragmatic trials; statistical power of clinical trials; judgment criteria (primary, secondary outcome, quality criteria to be considered for a relevant outcome, etc.); patient-reported outcome measure (PROM) (HRQoL, psychometric properties of questionnaires; EMA-FDA requirements); statistical analysis of a clinical trial (statistical effect, intention-to-treat analysis, intermediate analyses, subgroup analyses, survival analyses, validation of a surrogate marker, etc.); monitoring of clinical trials (role of sponsor, role of CRA, etc.) ; methodological biases in clinical trials; good clinical practices ; registries of clinical trial (e.g. clinicaltrial.gov) ; critical reading of randomized controlled trials (good research practice, reporting guidelines, EQUATOR network, etc.); non-pharmacological clinical trials; patient's preference for treatment characteristics (example of a Discrete Choice Experiment); cost-effectiveness analyses; publication of a clinical trial ; good research practice (introduction to meta-research, pressure of publication, fraud in clinical trials, etc.); etc.
Written exam (55%), visit attendance and report (30%), work presentation (poster) (15%).
The Course Clinical Trials s based upon the following books:
Training | Study programme | Block | Credits | Mandatory |
---|---|---|---|---|
Master 120 en sciences pharmaceutiques, à finalité approfondie | Standard | 0 | 6 | |
Master 60 en sciences biomédicales | Standard | 0 | 6 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique | Standard | 0 | 6 | |
Master 120 en sciences pharmaceutiques, à finalité spécialisée | Standard | 0 | 6 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique | Standard | 0 | 6 | |
Master 60 en sciences biomédicales | Standard | 1 | 6 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique | Standard | 1 | 6 | |
Master 120 en sciences pharmaceutiques, à finalité spécialisée | Standard | 1 | 6 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique | Standard | 1 | 6 | |
Master 120 en sciences pharmaceutiques, à finalité approfondie | Standard | 1 | 6 |