Clinical Trials
- UE code MSBMM103
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Schedule
24 30Quarter 1
- ECTS Credits 6
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Language
Anglais
- 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 ; 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; publication of a clinical trial ; good research practice ; etc.
Written exam with open questions.
The Course Clinical Trials s based upon the following books:
Training | Study programme | Block | Credits | Mandatory |
---|---|---|---|---|
Master in Pharmacy, Research focus | Standard | 0 | 6 | |
Master in Biomedical Sciences | Standard | 0 | 6 | |
Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 0 | 6 | |
Master in Pharmacy, Professional focus | Standard | 0 | 6 | |
Master in Biomedical Sciences, Professional focus in Clinical Research | Standard | 0 | 6 | |
Master in Biomedical Sciences | Standard | 1 | 6 | |
Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 1 | 6 | |
Master in Pharmacy, Professional focus | Standard | 1 | 6 | |
Master in Biomedical Sciences, Professional focus in Clinical Research | Standard | 1 | 6 | |
Master in Pharmacy, Research focus | Standard | 1 | 6 |