Learning outcomes

At the end of this course, students will be able to design the protocol of a clinical trial. 

Goals

In this course, students will be tasked with designing a clinical development plan (Phase I, Phase II, or Phase III study) for a lead compound that has just completed pre-clinical investigations. The objective is to simulate real-world scenarios where students must apply their knowledge to create a comprehensive clinical trial protocol. The students are free to develop a complete development plan (i.e. full protocol of Phase I and Phase II and Phase III) or a more extensive version of a protocol of a particular study phase (Phase I or Phase II or Phase III). The product may be a real product or a hypothetical one. 

Content

The structure of this course consists of an introductory session to present the course objectives, followed by a flexible, student-driven approach. The primary format of this course is based on tutoring sessions, which will be provided upon request to the main tutor. Students will work at their own pace, progressing through the design and development of their clinical trial protocols. 

Exercices

A case study is assigned to each group of 2 or 3 students.

Teaching methods

Flipped classroom and tutoring sessions.

Assessment method

Students will be divided into small groups (2–3) to work on a clinical study.

The final examination will consist of a comprehensive report presenting the clinical trial protocol developed by each group. This report will be evaluated based on its completeness, scientific rigor, and feasibility.


Language of instruction

English