CLINICAL STUDY MANAGEMENT
André Marc - Geysels Yves (20 h - 3 ECTS)
Professor Marc André is the current Head of the department of Hematology at the CHU UCL Namur, Yvoir, Belgium. He is the Vice-President of the LYmphoma Study Association (LYSA), member of the scientific board of LYSA and President of the Hodgkin Lymphoma Committee of LYSA. Professor André is President of the JACIE committee at the CHU UCL Namur, Yvoir, Belgium. He is also Professor of Clinical Trial Management at the Université de Namur, Namur, Belgium. He received his medical degree from the Université Catholique de Louvain in 1989, a professional training at the Hôpital Saint-Louis in Paris, France (1994-95) and became a board certified Hematologist. Prof. André has a broad range of translational scientific and clinical interests, spanning Hodgkin and non-Hodgkin lymphomas and late toxicities, design and conduction of clinical trials, and clinical management. Currently, he is a principal investigator of the international H10 and BREACH studies. He has published over 70 peer-reviewed papers and several book chapters.
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: 20 h
| Title | Clinical Study Management (3 ECTS) |
| Program
|
Next to the fundamental course on ‘Clinical Trials’, this course puts more emphasis in the practice of the theoretical concepts.
The role of clinical study manager will be explained. Applicable software system used by biotechnology and pharmaceutical industries will be explained as well, with focus on planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones. The course will highlight the following topics: – Efficient recruitment of trial participants – The importance of education and experienced study personnel – Publication of trial results and dissemination |
| 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 learn that managing clinical trials requires an efficient study management of every single aspect of the study in order to be successful;
Student will receive insights about the role of the Clinical Study Manager (CSM) and will learn that CSM leads all aspects of the study and provides continuous feedback on recruitment, site selection, and how to run each phase, throughout the entire duration of the trial; Student will be aware that the clinical trial management team proactively monitors study milestones to ensure the study is not only successful, but delivered on time and on budget; Student will understand the need of a Clinical Trial Management System (CTMS) database, a web-based tool that provides sponsors with access to near real-time data and study metrics, empowering clinical trial managers to deliver powerful solutions throughout the drug development process. |
| Prerequisites | Clinical Trials. |
| Teaching methods | PowerPoint presentation is used during classes and made available.
Class contact teaching. |
| Exam modality | Oral examination. |
TITLE
Clinical Study Management (3 ECTS)
PROGRAM
Next to the fundamental course on ‘Clinical Trials’, this course puts more emphasis in the practice of the theoretical concepts.
The role of clinical study manager will be explained.
Applicable software system used by biotechnology and pharmaceutical industries will be explained as well, with focus on planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
The course will highlight the following topics:
– Efficient recruitment of trial participants
– The importance of education and experienced study personnel
– Publication of trial results and dissemination
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 learn that managing clinical trials requires an efficient study management of every single aspect of the study in order to be successful;
Student will receive insights about the role of the Clinical Study Manager (CSM) and will learn that CSM leads all aspects of the study and provides continuous feedback on recruitment, site selection, and how to run each phase, throughout the entire duration of the trial;
Student will be aware that the clinical trial management team proactively monitors study milestones to ensure the study is not only successful, but delivered on time and on budget;
Student will understand the need of a Clinical Trial Management System (CTMS) database, a web-based tool that provides sponsors with access to near real-time data and study metrics, empowering clinical trial managers to deliver powerful solutions throughout the drug development process.
PREREQUISITES
Clinical Trials.
TEACHING METHODS
PowerPoint presentation is used during classes and made available.
Class contact teaching.
EXAM MODALITY
Oral examination.
Last modified: Dicember 17, 2019