Learning outcomes

  • The student will be familiar with the major principles of research adopted in clinical trials;
  • The student will be able to recognize the different types of clinical trials and understand the key methodological aspects of these various trial types;
  • The student will grasp the various key components of a clinical trial protocol and be capable of critically reviewing it;
  • The student will comprehend the main statistical analyses applied in clinical trials and be able to interpret them;
  • The student will be able to analyze potential methodological biases that may be present in a clinical trial. Furthermore, the student will be familiar with good research practices (EQUATOR);
  • The student will be familiar with regulatory requirements, ethical considerations, and Good Clinical Practice (GCP).
  • The student will understand the importance of publishing the results of a clinical trial and will have gained a foundation in meta-research in the field of clinical trials.

Goals

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

Content

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 regulatory authorities ; 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.

Table of contents

  • Introduction

  • Different designs of clinical trials – part 1

  • Different designs of clinical trials – part 2

  • Randomized controlled trial protocols – part 1

  • Randomized controlled trial protocols – part 2

  • Statistics in clinical trials – part 1

  • Statistics in clinical trials – part 2

  • Bias in clinical trials – part 1

  • Bias in clinical trials – part 2

  • Use of questionnaires in clinical research

  • Ethics, regulatory authorities and GCP (Good Clinical Practice) in clinical trials

Exercices

  • Some course sessions will be accompanied by a practical or guided exercise directly related to the material covered during that session.

  • Students will work in groups on an assignment consisting of a critical appraisal of a published clinical trial, presented in a "poster" format.

  • All other exercices are described in the Course Book

Co-requisites

  • Statistics Applied to Biomedical Sciences [MSBMM104]
  • Bioethics [MSBMM113]

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.


Theoretical classes


  • Presentations in the form of PowerPoint slides during the lessons — the materials will be made available on Webcampus.

  • In-class exercises.

  • Preparation of an exercise to be completed at home.

Practical classes

  • Group exercise – Presentation of a clinical trial in poster format – preparation at home and presentation in class

  • Take-home exercises – Good Clinical Practice (GCP)

  • Practical session on research protocols

  • Visits to clinical research sites

  • ECCRT: Virginie Hamtiaux – Careers in Clinical Research

  • Active participation in a mini scientific symposium organized at UNamur

    Attendance for the entire day is mandatory. Attendance will be recorded at the beginning and end of the day. Any absence from the mini symposium will result in a 3-point deduction from the written exam grade (out of 20)

Assessment method

Written exam with open questions.

Sources, references and any support material

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. Statistics Applied to Clinical Studies, Fifth Ed.Ton J. Cleophas, Aeilko H. Zwinderman. 2012
  4. Epidemiology - Study design and data analysis - Third Ed. Mark Woodward. 
  5. Drugs: from discovery to approval, 2nd Ed., Rick Ng, Wiley-Blackwell, 2009; 3rd Ed. June 2015
  6. 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

English
Training Study programme Block Credits Mandatory
Master in Pharmacy Finalité approfondie 1 6 Yes
Master in Pharmacy Finalité spécialisée 1 6 Yes
Master in Biomedical Sciences Filière en gestion de la recherche clinique 1 6 Yes
Master in Biomedical Sciences Standard 1 6 Yes