The general objective of this MOOC is to give health professionals, students and researchers the theoretical and practical bases which will allow them to design clinical trials that meet these criteria. This MOOC, which covers all areas of health, focuses specifically on resource-limited countries. This MOOC, created by the Institut Pasteur in Paris in collaboration with partners involved in clinical trials (Institute of Research for Development -IRD, Drugs for Neglected Diseases initiative -DNDi, etc.), provides the theoretical bases for the clinical investigation and examples of trials in resource-limited countries.
This MOOC is organized in 5 chapters of 2 to 11 sessions each. Each session includes a short video and 2 multiple choice questions in French and English to help you test your understanding. There are 4 to 22 multiple choice questions at the end of each chapter. A certification exam (in English or in French) is accessible only for students registered to the “qualifying path”. The videos are in French, subtitles in English and French are provided.
Please note, only the "Qualifying" path gives the right to a qualifying certification issued by Fun and the Institut Pasteur. In addition, there will be no certificate of follow-up, neither for the "Discovery" path, nor for the "Qualifying" path
We recommend a good scientific background (such as a bachelor of life science).
This MOOC is aimed at anyone who wants to learn more about the methodology of clinical trials, particularly concerning infectious and tropical diseases in Africa. The content is appropriate for epidemiologists, infectious diseases specialists, general practitioners, microbiologists, other health workers, students in life sciences and medicine, as well as employees of non-governmental organizations or health agencies.
Assessment and certification
To follow this course, you have the choice between two formulas: the DISCOVERY path which will allow you to familiarize yourself with the subject thanks to videos, quizzes and access to forums and the QUALIFYING path in which you can acquire skills and deep knowledge on the subjects.
- Discovery path
If you opt for this path, you will have access to the videos, the quizzes and the exchanges in the forum. For this path, no certificate will be delivered. The registration is free.
- Qualifying path
In addition to the activities offered in the DISCOVERY path, the QUALIFYING formula will allow you to obtain a certificate in the form of a "certificate". To do this, you will have to take a exam, monitored remotely, lasting 1 hour, consisting of 30 multiple choice questions (MCQ) and obtaining 18 correct answers.
The registration fee for the qualifying course is 150€.
Obtaining a qualifying certification is an opportunity for you to obtain a diploma. This course is one of the MOOCs of the Institut Pasteur's Digital Diploma in Infectious Diseases program (DNM2IP). For more information, see the Institut Pasteur web page, dedicated to this new diploma.
Chapter 1 - Introduction (2)
- W1-1: History of clinical trials. (Jean-Christophe Thalabard)
- W1-2: Different phases of drug development. (Soizic Courcier)
Chapter 2 - Methodology (11)
- W2-1 : The major methodological principles. (Muriel Vray)
- W2-2 : Types of clinical trials : Explanatory trials (Superiority versus Non inferiority). (Muriel Vray)
- W2-3 : Types of clinical trials :Pragmatic trials. (Muriel Vray)
- W2-4 : Types of clinical trials : community trials. (Jean-Christophe Thalabard)
- W2-5 : Types of clinical trials : adaptative trials and Bayesian methods. (François Montestruc)
- W2-6 : Randomization. (François Montestruc)
- W2-7 : Sample size calculation. (François Montestruc)
- W2-8 : Data analysis : Intention to treat versus per protocol. (Muriel Vray)
- W2-9 : Présentation des résultats (Consort) /Presentation of results (Consort). (Muriel Vray)
- W2-10 : Different types of analyses (Interim analysis/Subgroup analysis). (François Montestruc)
- W2-11 : Specificities of vaccine trials. (Soizic Courcier)
Chapter 3 - Management of clinical trials (5)
- W3-1: The team and the implementation. (Nathalie Jolly)
- W3-2: The protocol. (Gwenaëlle Carn)
- W3-3: The CRF. (Gwenaëlle Carn)
- W3-4: Data management. (Julie Le Boulicaut)
- W3-5: Implementation and follow-up. (Cassandre von Platen)
Chapter 4 - Ethics and regulatory issues (3)
- W4-1: Good clinical practices and international recommendations. (Olivia Chény)
- W4-2: Authorities and ethical committees. (Olivia Chény)
- W4-3: Patient safety monitoring. (Nathalie Jolly)
Chapter 5 - Examples of clinical trials (8)
- W5-1 : African trypanosomiasis : a non-inferiority trial. (Olaf Valverde)
- W5-2 : Specificities of clinical trials on tuberculosis. (Maryline Bonnet)
- W5-3 : Management of patients with HIV-1 group 0 in Cameroon. (Guillemette Unal)
- W5-4 : HIV Trial. (Christian Laurent)
- W5-5 : Single blind, non-inferiority trial on the immunogenicity and safety of fractionated doses of vaccine against Yellow Fever. (Rebecca Grais)
- W5-6 : Randomised trial on prevention of gestational malaria in Benin. (Valérie Briand)
- W5-7 : Impact of ciprofloxacin as a prophylaxis for a meningococcus meningitis epidemic in villages. (Rebecca Grais)
- W5-8 : Particularities of clinical trials in low-middle income countries. (Nathalie Strub-Wourgraft)
Other course runs
- From Sept. 21, 2020 to Nov. 16, 2020