The general objective of this course is to give to health professionals, students in healthcare professions and researchers working in the field, the theoretical and practical basics to enable them to design and monitor clinical trials that meet International quality standards as ICH-GCP (International Conference on Harmonization - Good Clinical Practices). This course that addresses all health areas will focus on aspects related to countries with limited resources.
Telephone: +221 33 839 92 47
E-Mail: GwenaelleCarn@pasteur.mg / Telephone: +261 32 98 344 69
Applicants will have to bring with them a laptop and a calculator.
An evaluation based on an examination will be conducted at the end of the course.
Course participation is free as well as lunch. For applicants not living in Senegal, financial support is possible.
Location: This course will be located at the Institut Pasteur in Dakar, SENEGAL
Dates: From 3 to 14 of July 2017
Application deadline: 30 April 2017
The course comprises:
The course alternately will include theoretical lectures with emphasis on the main principles in clinical trials including superiority and non-inferiority trials or new methodology (how to perform randomizations, how to handle missing data, adaptive design, etc…). and tutorials. It will be preceded by three days of introduction to epidemiology and the basics of statistics.
The content of the program is:
3 days for the introduction to epidemiology and the basics of statistics
4 days for clinical trials methodology. The following topics will be presented :
The main principles of clinical trials and new methodologies used on specific populations or emergencies (adaptive methods, sequential trials...) and specific methods of interventional trials (community trials).
Students will be taught how to read and interpret Clinical Trial report and its publication. These methods will be illustrated with examples.
Clinical research ethics: conceptual and operational definitions of ethics in research and their implications in different situations, good clinical practice and ethical rules to ensure the protection and rights of individuals and those governing biological collections and databases.
1 day dedicated to regulatory and legal aspects (description of the different actors and their responsibilities) and pharmacovigilance. The perspectives of anthropology in clinical research will also be discussed.
1 day during which local partners will present their experience in completed, on-going trials or trials to be set up in Senegal and Madagascar: antiretroviral trials, vaccine trial, interventional trial in malnourished children....
- 1 day for the final exam
A committee, including M Vray, G Carn, A Harimanana, A Touré, C Talla et C Loucoubar, will evaluate applications.
Documents available to download:
Muriel VRAY, Institut Pasteur of Dakar, Senegal
Gwenaelle CARN, Institut Pasteur of Madagascar
Attendees: 20 max
Duration: 2 weeks
Contact: Muriel Vray,
Tel : +221 33 839 92 47
- Muriel Vray, Institut Pasteur Dakar, Senegal
- Gwenaelle Carn, Institut Pasteur Madagascar
- Aina Harimanana, Institut Pasteur Madagascar
- Cheikh Talla, Institut Pasteur Dakar, Senegal
- Cheikh Loucoubar, Institut Pasteur Dakar, Senegal
- Aissatou Touré, Institut Pasteur Dakar, Senegal
- Moussa Seydi, CRCF Fann, Dakar, Senegal
- Cheikh Sokhna, IRD Dakar, Senegal
- Bernard Taverne, IRD, Dakar, Senegal
- Gabrièle Laborde-Balen, ANRS, Dakar, Senegal
- François Montestruc, eXYSTAT, Malakoff, France
- Soizic coursier, GSK, Belgique