Education

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

€ 710

Location

Erasmus MC, Rotterdam NL

Level

Intermediate

Prerequisites

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

Disciplines

  • Clinical Epidemiology

Application

Go to the ESP website

Downloads

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


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

Institute of Medical Education Research Rotterdam (iMERR)

Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital

  • Department of Cancer Epidemiology

25% reduction on our fees for partner institutes of NIHES

For participants formally appointed at the following departments, institutes:

  • Departments of Erasmus MC (except the departments mentioned above)
  • Addiction Research Institute (IVO)
  • Integraal Kankercentrum Zuid (IKZ)
  • Pallas Health Research and Consultancy
  • Municipal Health Service Amsterdam (GGD Amsterdam)
  • Municipal Health Service Rotterdam (GGD Rotterdam)
  • Havenpolikliniek
  • Admiraal De Ruyter Ziekenhuis

25% reduction for all (international) PhD students
Please state your supervisor/promotor’s name and email address 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.