Advanced Clinical Trials [EWP10]
Monday to Friday (5 full days), assignment is due a week after the final course day.
Prof. Myriam Hunink, MD, PhD, Tim Clayton, PhD
Erasmus MC, Rotterdam NL
Introductory courses in clinical epidemiology and medical statistics.
- Clinical Epidemiology
Detailed information about this course:
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.
The final assignment of this course is due 1 March 2019.
- 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
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.
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:
- 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 partner institutes of NIHES
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.