Learning outcomes

  • The student will have learned to identify the key factors that can lead to the failure of a clinical trial and will be able to identify potential solutions to avoid these failures;
  • The student will be aware of the issues and strategies related to research transparency requirements. The student will be able to identify the role(s) of the Clinical Trial Manager in meeting these research transparency requirements.

 

Goals

Enable students to deepen their knowledge of the main aspects of practical clinical trial management. ; the student will develop a critical analysis of the conduct/reporting of clinical trials. 

Content

  1. Factors associated with clinical trials that fails
  2. False data in clinical trials. 
  3. Free theme

Exercices

See teaching methods

Teaching methods

The course will be conducted in a Problem-Based Learning format.

The three main themes covered will be: 1. Factors associated with failed clinical trials; 2. False data in clinical trials ; 3. Free theme. 

For each theme, a series of learning objectives will be developed. Students will be required to address these learning objectives based on readings provided by the instructor. Preparatory work at home will be necessary and will be followed by a tutorial session during which students will discuss the topic and collectively address the learning objectives.

 

Assessment method

Preparation + participation to the four discussion sessions (tutorials) (50%)

Production of a written report incorporating a response to all learning objectives. The written report will be organized according to the three main themes covered during the course (50%)

Sources, references and any support material

The various resources needed to meet the learning objectives will be provided to students during class sessions.

Language of instruction

English