Advanced Clinical Trials [EWP10]

Course highlights

ECTS

1.9

Start date

26-02-2018

End date

02-03-2018

Course days

Monday to Friday (5 full days)

Faculty

Prof. Myriam Hunink, MD, PhD, Tim Clayton, PhD

Course fee

€ 1190

Location

Erasmus MC, Rotterdam NL

Level

Intermediate Advanced

Prerequisites

Introductory courses in clinical epidemiology and medical statistics.

Disciplines

  • Clinical Epidemiology

Exam date

06-03-2018

Resit date

04-05-2018

Application

How to apply

Detailed information about this course:

Description

The Randomized Controlled Clinical Trial (RCT) is the most reliable  method of assessing the efficacy and effectiveness of interventions. In order to provide the best possible evidence-based health care, health professionals must be able to judge the scientific merits and clinical relevance of published RCTs. In addition, they may be involved in designing and performing a RCT and are frequently asked to recruit patients for RCTs.

Reports published in major medical journals show a surprising variability in methods including choice of study design, blinding, avoidance of bias, outcome measures, effect parameters, sample size calculations, data analysis techniques, presentation of results in tables and figures, and inferences made from the results. Hence, appraising trial reports can be challenging. In designing RCTs many difficult decisions need to be made with respect to these same issues.

In this course these topics and issues will be addressed and developed through lectures and group practical sessions. A laptop during classroom sessions is required in order to do the practical assignments.


Objectives

  • Be able to critically appraise and interpret intervention research
  • Understand study design issues related to both pharmacological and non-pharmacological interventions
  • Understand potential forms of bias in intervention research 
  • Understand the key features of non-inferiority RCTs, factorial RCTs, cross-over RCTs, cluster RCTs, stepped wedge cluster RCTs, pre-randomization, preference trials, cohort multiple RCT, SMART designs, MAMSdesign, basket master protocols, umbrella master protocols, platform designs, and adaptive design
  • Be able to design a study and understand the key elements of a study protocol
  • Understand practical issues in performing a clinical trial
  • Be able to analyse the data from a clinical trial and make justified inferences from the results
  • Be able to synthesize data from published clinical trials 

Participant profile

Medical doctors and medical students involved in patient care or in clinical research. Researchers, clinical epidemiologists, biostatisticians, health technology assessors, and public health professionals with an interest in clinical trials.

Assessment

Written exam, Assignment(s)


Reduction on fees

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

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 tutor’s name and email address on the application form (remarks field).