Learning outcomes

  • The student will have learned to identify the main factors that can lead to the failure or success of a clinical trial.
  • The student will be made aware of the issues associated with poor research practices and their potential impact on the field of clinical research.
  • The student will also be made aware of the overreporting of benefits and underreporting of risks in clinical research.

 

Goals

To enable students to deepen their knowledge of the main methodological aspects of clinical studies and to develop their critical thinking skills when reading, understanding, and analyzing clinical trials.

Content

Three main themes will be covered by the course:

  1. Factors associated with clinical trial failure and success
  2. Faked and flawed clinical trials – Are we in the middle of a scientific crisis?
  3. Benefit-risk balance: the problem of over-reported benefits and under-reported risks

Exercices

See teaching methods

Teaching methods

A course book will be provided to students at the beginning of the course; it will include an introduction, the course structure, the educational format, the schedule, the course objectives, the examination modalities, the language of instruction, and the professor’s contact information.


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

The three main themes covered will be:


  1. Factors associated with clinical trial failure and success
  2. Faked and flawed clinical trials – Are we in the middle of a scientific crisis?
  3. Benefit-risk balance: the problem of over-reported benefits and under-reported risks


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