CLINICAL TRIALS

Geysels Yves (48 h - 6 ECTS)

Yves Geysels is Visiting Professor of Clinical Trials at the Faculty of Medicine, Department of Biomedical Sciences and has authored more than 50 publications. Currently he is also Director of Clinical Operations at Bone Therapeutics, a bone cell therapy company, specializing in addressing unmet medical needs in the field of orthopaedics and bone diseases. Yves has a vast experience of more than 20 years in managing clinical trials from an operational point of view, within pharmaceutical companies and Contract Research Organizations (CRO), prior joining the Biotech Industry in 2018. He is founder and honorary president of the Belgian Association of Clinical Research Professionals (ACRP.be) and a honorary fellow at the University of Brussels (VUB).

Theory: 24 h

Exercises: 24 h

Title	Clinical trials (6 ECTS)
Program	The student will get an overview of the entire process of Clinical Drug Development. Using the “standard” drug development as an example, some particular other settings (pediatric clinical trials, medical device studies) are also discussed. The current rules and regulations are explained and put into a historical perspective. The course will teach how the different actors are involved in clinical drug research, about the respective roles and the way they interact between one another. Through some practical exercises and visits to phase 1, CRO and pharmaceutical companies, student will have better insights how medication is distributed, stored and administered to subjects, how the coordination in Clinical Trials Centers happens and what the different source documents look like. The course will discuss some ethical questions, new trends in Clinical Development, innovative ways to recruit subjects in Clinical trials, adaptive design, concept of Lean and the latest trends in Clinical research. At the end we tackle the Belgian Clinical Trials Law, as well as the new European Regulation on Clinical trials that will come into force by end of 2017
Sources	The Course is 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/ Clinical Trials. G Bouvenot & M Vray, 4th Ed., Medicine-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
Objectives and expected results	Student will know the historical background of the current rules and regulations, through a couple of cases that led to the creation of FDA, EMA and Pharmacovigilance; Student will have gained insights in the complex process of the clinical phase of drug development as well as medical devices development by pharmaceutical and biotechnological companies and will understand the registration of new drugs and its challenges; Student will understand the evolving importance of contract research organizations (CRO) and the impact of outsourcing in health related research; Student will have knowledge on the different actors involved in this process, and are capable of describing their specific roles such as CTA, CRA, RSU, sponsor, CRO, research team, investigator, Quality Assurance, Quality Management, Ethics Committee and Regulatory Agencies; Student will become capable of using own knowledge in practice, during an internship in a clinical research environment.
Prerequisites	Basic knowledge of statistics and preclinical drug development.
Teaching methods	PowerPoint presentation is used during classes and made available. Class contact teaching (Lectures and Practice sessions). Visits to Clinical Trials Centers, Phase I unit, Contract Research Organizations and a Hospital pharmacy. Students will receive some exercises to prepare and present. Thorough understanding on how to write an Informed Consent Form based upon a real-life protocol. Identify the important criteria that defines a correct ICF. Furthermore, students will receive a case study to prepare as well with regard to a recent phase 1 accident, which occurred in a first in human study.
Exam modality	Written examination.

TITLE

Clinical trials (6 ECTS)

PROGRAM

The student will get an overview of the entire process of Clinical Drug Development. Using the “standard” drug development as an example, some particular other settings (pediatric clinical trials, medical device studies) are also discussed. The current rules and regulations are explained and put into a historical perspective. The course will teach how the different actors are involved in clinical drug research, about the respective roles and the way they interact between one another. Through some practical exercises and visits to phase 1, CRO and pharmaceutical companies, student will have better insights how medication is distributed, stored and administered to subjects, how the coordination in Clinical Trials Centers happens and what the different source documents look like. The course will discuss some ethical questions, new trends in Clinical Development, innovative ways to recruit subjects in Clinical trials, adaptive design, concept of Lean and the latest trends in Clinical research. At the end we tackle the Belgian Clinical Trials Law, as well as the new European Regulation on Clinical trials that will come into force by end of 2017.

SOURCES

The Course is 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/ Clinical Trials. G Bouvenot & M Vray, 4th Ed., Medicine-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

OBJECTIVES AND EXPECTED RESULTS

Student will know the historical background of the current rules and regulations, through a couple of cases that led to the creation of FDA, EMA and Pharmacovigilance;

Student will have gained insights in the complex process of the clinical phase of drug development as well as medical devices development by pharmaceutical and biotechnological companies and will understand the registration of new drugs and its challenges;

Student will understand the evolving importance of contract research organizations (CRO) and the impact of outsourcing in health related research;

Student will have knowledge on the different actors involved in this process, and are capable of describing their specific roles such as CTA, CRA, RSU, sponsor, CRO, research team, investigator, Quality Assurance, Quality Management, Ethics Committee and Regulatory Agencies;

Student will become capable of using own knowledge in practice, during an internship in a clinical research environment.

PREREQUISITES

Basic knowledge of statistics and preclinical drug development.

TEACHING METHODS

PowerPoint presentation is used during classes and made available.

Class contact teaching (Lectures and Practice sessions).

Visits to Clinical Trials Centers, Phase I unit, Contract Research Organizations and a Hospital pharmacy.

Students will receive some exercises to prepare and present.

Thorough understanding on how to write an Informed Consent Form based upon a real-life protocol.

Identify the important criteria that defines a correct ICF.

Furthermore, students will receive a case study to prepare as well with regard to a recent phase 1 accident, which occurred in a first in human study.

EXAM MODALITY

Written examination.

Last modified: April 29, 2021

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