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 design, conduct and analysis issues of clinical trials. We will discuss the clinical, scientific, and regulatory aspects of clinical trials, which investigate the efficacy and safety of candidate treatments or of diagnostic procedures. We will cover issues regarding the design such as the identification of the target population, choice and definition of the intervention and the comparators, choice and definition of study outcomes and assumptions needed to determine the size of the trial. Regarding the conduct and implementation of clinical trials we will cover the need for trial registration, 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. Throughout the course emphasis is placed on pre-specification of these elements in a well-defined study protocol and on documentation of implementation and conduct of the study.

Teaching methods:

Lectures and group work on critical appraisal of published clinical studies with a focus on randomized trials.

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 design, conduct and implementation of clinical trials.

Assessment

Attendance