Clinical Trials [ESP14]

Course highlights

EC points

0.7

Months

August

Course days

Monday to Friday (5 afternoons)

Faculty

Prof. Marcel Zwahlen, Dr. Sven Trelle

Course fee

€ 740

Location

Erasmus MC, Rotterdam NL

Level

Intermediate

Prerequisites

Introductory level epidemiology (e.g. the course Principles of Research in Medicine).

Disciplines

  • Clinical Epidemiology

Application

How to apply

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


Reduction on fees

PLEASE NOTE THIS DOES NOT APPLY TO THE RESEARCH MASTERS (120 EC points)

50% reduction on our fees for participating institutes of NIHES

This 50% reduction is offered to participants formally appointed at the departments or sections participating in NIHES.

University Medical Center Rotterdam/Erasmus University Rotterdam:

  • Department of Epidemiology
  • Department of Public Health
  • Department of Psychiatry, Section of Medical Psychology and Psychotherapy
  • Department of Child and Adolescent Psychiatry/Psychology
  • Department of Medical Informatics
  • Department of General Practice
  • Erasmus School of Health Policy & Management
  • Generation R

50% reduction on our fees for NIHES affiliated partners

This 50% reduction is offered to participants formally appointed at the following NIHES affiliated partners:

University Medical Center Rotterdam/Erasmus University Rotterdam, departments of:

  • Dermatology
  • General Paediatrics
  • Plastic and Reconstructive Surgery
  • Rehabilitation Medicine

UMIT, Department of Public Health, Health Services Research and Health Technology Assessment.

25% reduction on our fees for Erasmus MC employees

For participants formally appointed at all departments of Erasmus MC (except the departments mentioned above).

25% reduction for all (international) PhD students
Please upload proof of enrollment as a PhD student in the application form and state the name of your tutor on the application form (remarks field).

25% reduction on our course fees (maximum 3 EC points per academic year) for all NIHES alumni
Please state that you are a NIHES alumnus/alumna and the academic year you graduated (remarks field). Please note that the reduction on fees for alumni does not apply to the Erasmus Summer Programme.