Advanced Clinical Trials [EL013]

Course highlights

EC points

1.9

Start date

14-03-2022

End date

18-03-2022

Course days

Monday to Friday (5 full days), assignment is due a week after the final course day.

Faculty

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

Course fee

€ 1180

Location

Hybrid

Level

Intermediate Advanced

Prerequisites

Introductory courses in clinical epidemiology and medical statistics.

Disciplines

  • Clinical Epidemiology

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.

Disclaimer: This course is part of a trial with hybrid courses (can be followed both at Erasmus MC and online). In the event the hybrid setup is no longer possible, the course will be taught fully online in order to ensure all participants are able to join the course. However, we fully intend to organize this course as a hybrid course. Participants will be asked at a later stage to indicate whether they want to participate in class or online - note that there are limited in-class places available.

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

Assignment(s)


Reduction on fees

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

No fees are charged for participation of Erasmus MC PhD candidates

Please note that in case of cancellation or no show, the cancellation policy applies based on the full course fee.

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 and Erasmus MC PhD candidates).

25% reduction for all (international) PhD students without formal appointment at Erasmus MC

Upon receipt of your application you will receive a request to upload proof of enrollment as a PhD student.