Clinical trials in infectious and tropical diseases
Ref. 96018
This MOOC covers the theoretical and practical foundations of clinical research and presents examples of clinical trials conducted in low-resource countries.
- Duration: 8 weeks
- Effort: 29 hours
- Pace: ~3h30/week
- Languages: English and french
What you will learn
At the end of this course, you will be able to:
- Describe the main methodological principles of clinical trials.
- Define the specificities of clinical trials in low-resource countries.
- Identify the methodology to be applied according to the purpose of the trial: explanatory, pragmatic, community-based, etc.
- Understand the practical aspects of setting up and managing clinical trials.
- Identify good clinical practice from an ethical point of view and in accordance with international regulatory aspects.
- Participate in the development of clinical trials that meet methodological and ethical criteria.
Description
The general objective of this MOOC is to give professionals, students and researchers working in the field of Life Sciences and Health, the theoretical and practical basis that will enable them to design clinical trials that meet international criteria of ethics and quality. This course, which addresses all areas of health care, deals with aspects more specifically related to countries with limited resources.
Format
This MOOC consists of 5 teaching chapters. Each chapter consists of 3 to 11 sequences. Each sequence consists of a video of about 10 minutes and a MCQ so that students can test their knowledge.The videos are in French with French and English subtitles.
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Prerequisites
A good scientific level is recommended to follow this MOOC (Bachelor in Life Sciences).
Assessment and certification
To follow this course, you can choose between two options:
- The Discovery Course gives access to videos, quizzes and discussions in the forum. No badge is issued for this course. Registration is free.
- The Qualifying Course leads to a certificate. In addition to the activities of the Discovery Course, you will have to take a one-hour supervised distance learning exam, consisting of 30 multiple choice questions (MCQs) and 18 correct answers. The registration fee for the Qualifying Course is 150€.
Successful completion of the Qualifying Course gives you the opportunity to apply for the The Institut Pasteur Online Diploma of Infectious Diseases (DNM2IP), which consists of 5 certificates to Institut Pasteur MOOCs on infectious diseases. To learn more about this diploma, visit the Institut Pasteur's web page dedicated to this diploma.
Course plan
- C1-1: History of clinical trials / Jean-Christophe Thalabard
- C1-2: Different phases of drug development / Soizic Courcier
- C2-1 : The major methodological principles / Muriel Vray
- C2-2 : Types of clinical trials : Explanatory trials (Superiority versus Non inferiority) / Muriel Vray
- C2-3 : Types of clinical trials :Pragmatic trials / Muriel Vray
- C2-4 : Types of clinical trials : community trials / Jean-Christophe Thalabard
- C2-5 : Types of clinical trials : adaptative trials and Bayesian methods / François Montestruc
- C2-6 : Randomization / François Montestruc
- C2-7 : Sample size calculation / François Montestruc
- C2-8 : Data analysis : Intention to treat versus per protocol / Muriel Vray
- C2-9 : Présentation des résultats (Consort) /Presentation of results (Consort) / Muriel Vray
- C2-10 : Different types of analyses (Interim analysis/Subgroup analysis) / François Montestruc
- C2-11 : Specificities of vaccine trials / Soizic Courcier
- C3-1: The team and the implementation / Nathalie Jolly
- C3-2: The protocol / Gwenaëlle Carn
- C3-3: The CRF / Gwenaëlle Carn
- C3-4: Data management / Julie Le Boulicaut
- C3-5: Implementation and follow-up / Cassandre von Platen
- C4-1: Good clinical practices and international recommendations / Olivia Chény
- C4-2: Authorities and ethical committees / Olivia Chény
- C4-3: Patient safety monitoring / Nathalie Jolly
- C5-1 : African trypanosomiasis : a non-inferiority trial / Olaf Valverde
- C5-2 : Specificities of clinical trials on tuberculosis / Maryline Bonnet
- C5-3 : Management of patients with HIV-1 group 0 in Cameroon / Guillemette Unal
- C5-4 : HIV Trial / Christian Laurent
- C5-5 : Single blind, non-inferiority trial on the immunogenicity and safety of fractionated doses of vaccine against Yellow Fever / Rebecca Grais
- C5-6 : Randomised trial on prevention of gestational malaria in Benin / Valérie Briand
- C5-7 : Impact of ciprofloxacin as a prophylaxis for a meningococcus meningitis epidemic in villages / Rebecca Grais
- C5-8 : Particularities of clinical trials in low-middle income countries / Nathalie Strub-Wourgraft
Course team
Organizations
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License
License for the course content
Attribution-NonCommercial-NoDerivatives
You are free to:
- Share — copy and redistribute the material in any medium or format
Under the following terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- NonCommercial — You may not use the material for commercial purposes.
- NoDerivatives — If you remix, transform, or build upon the material, you may not distribute the modified material.
License for the content created by course participants
Attribution-NonCommercial-NoDerivatives
You are free to:
- Share — copy and redistribute the material in any medium or format
Under the following terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- NonCommercial — You may not use the material for commercial purposes.
- NoDerivatives — If you remix, transform, or build upon the material, you may not distribute the modified material.