Clinical Trials [ESP14]

Detailed information about this course:

Description

Faculty: Prof. Marcel Zwahlen, PhD and Sven Trelle, MD, MSc

This basic and intermediate level course covers essential aspects of the design, conduct and analysis of clinical trials. We will discuss the scientific and methodological aspects of clinical trials investigating the efficacy and safety of candidate treatments. We will cover issues such as the choice and definition of study endpoints and assumptions needed to determine the size of the trial, choice of randomization strategies and procedures, the role of blinding, issues on prevention and handling of missing data, monitoring of the study, and the standards for the reporting of the trial results. We strongly recommend the pre-specification of these elements in the study protocol and the detailed documentation of the actual study conduct. We use real examples (publications) to explain the theoretical foundations of the methodological principles of clinical trails. The course will not provide detailed and technical implementation strategies to conduct a trial but rather aims at understanding principles.

Teaching methods:

Lectures and group work on critical appraisal of published (randomized) clinical trials.

Assessment:

Attendance / participation in group discussions

Objectives

After this course you should be able to:

• Critique the design, conduct and analysis of a (randomized) clinical trial.
• Design the fundamental characteristics of a clinical trial to address a clearly specified clinical question.
• Understand the challenges related to selected aspects of the conduct and implementation of a clinical trial.
  

Participant profile

Those interested in the fundamental aspects of the design, conduct and implementation of clinical trials.

Assessment

Attendance