By the end of this course, students will be able to:
Formulate a relevant and structured clinical research question and develop an appropriate literature search strategy.
Understand the different steps involved in conducting a systematic review and the fundamental statistical principles underlying meta-analysis.
Extract, organize and synthesize data from published studies and perform basic meta-analytical procedures using R/RStudio.
Critically interpret meta-analysis results, including effect sizes, forest plots, heterogeneity, subgroup analyses, sensitivity analyses and publication bias.
Identify strengths, limitations and potential sources of bias in available scientific evidence.
Use existing evidence to identify research gaps and justify new clinical research questions.
Translate a research question into a scientifically sound, methodologically coherent and feasible clinical trial protocol, including the definition of study design, population, intervention/comparator, endpoints and other key methodological components.
Critically justify methodological choices and work collaboratively within a clinical research team.
The overall objective of Research Practice Training is to introduce students to an integrated approach to clinical research, ranging from the critical appraisal and synthesis of existing evidence to the design of new clinical research.
The course aims to develop students' ability to understand what is already known about a clinical question, critically evaluate the available evidence, and identify uncertainties and research gaps that may justify further investigation. Students will subsequently learn how to translate a relevant scientific question into a structured and methodologically rigorous clinical research project.
The course consists of two complementary modules.
The first module focuses on systematic reviews and meta-analyses, including research question formulation, literature search strategies, study selection, assessment of study quality and risk of bias, data extraction and harmonization, effect size estimation, study weighting, fixed-effect and random-effects models, heterogeneity, subgroup analyses, meta-regression, sensitivity analyses, publication bias, and interpretation of forest plots and funnel plots. More advanced approaches, including individual participant data meta-analysis, network meta-analysis and GRADE assessment, are also introduced.
The second module focuses on clinical research design and clinical trial protocol development. Students address the scientific and clinical rationale, objectives and hypotheses, study design, study population and eligibility criteria, intervention and comparator, primary and secondary endpoints, study procedures and follow-up, safety assessments, statistical considerations, recruitment strategy, ethical considerations and study feasibility
The course combines different teaching approaches to integrate theoretical knowledge, practical application, critical interpretation and student autonomy.
Teaching methods include interactive lectures, class discussions and interpretation exercises, critical appraisal of published research, literature search and data extraction activities, and hands-on sessions using R/RStudio to apply meta-analysis methods to published data.
Clinical trial protocol development follows a project-based learning approach. Students work progressively and autonomously in small groups, supported by dedicated supervision sessions, tutoring and methodological guidance. This enables students to apply methodological concepts to the development of a realistic clinical research project.
Assessment is entirely written and consists of two complementary components, each accounting for 50% of the final grade:
Module 1: 50% – Individual written examination: Systematic Reviews and Meta-analyses. The examination assesses students' understanding of the methodological and statistical concepts covered during the course, as well as their ability to analyse and critically interpret systematic reviews and meta-analysis results.
Module 2: 50% – Written group report: Clinical Trial Protocol. Students submit the clinical trial protocol developed throughout the semester. The report is assessed according to its completeness, scientific and methodological rigor, and the feasibility of the proposed clinical study
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences | Filière en gestion de la recherche clinique | 1 | 4 | Yes |