Order courses: Course detail
Clinical Trials and Drug Risk assessment
Content partner
Julius Center
Course coordinator
Dr. G.C.M. van Baal
Description
| Course | Clinical Trials and Drug Risk Assessment (CE04) |
| Date | 9 - 13 December 2024 |
| Course co-ordinator | Dr. G.C.M.(Caroline) van Baal |
| Course description | A clinical trial is an exceedingly important instrument in the assessment of treatment efficacy. With regard to clinical trials, the emphasis will be on methodological principles and on the clinical practice of therapeutic experiments. Furthermore, this course addresses the principles of studying the effects of drug treatments on the risks of unintended effects. The accent is on proper formulation of the research problem with a view to clinical and regulatory relevance of the study results, and on requirements for validity in non-experimental research. The course program covers the principles of therapeutic research design, including design of study, design of data collection, design of data analysis, including some modelling techniques in the analysis to clinical trials, and the interpretation of its results. Finally the program covers the principles of drug risk assessment in the context of therapeutic research. Seminal lectures on trials and practical exercises are included in the program. |
| Course objectives | At the end of this course, the student - has insight in the basic design principles of a randomized controlled trial - has an overview of specialized design options for a randomized controlled trial - has insight in the basic principles of data analysis of a randomized controlled trial - has an overview of more specialized principles of data analysis of a randomized controlled trial - has insight in the principles of drug risk assessment and how to evaluate potential side effects of medication - has an overview of current regulatory principles for the conduct of randomized controlled trials - has an overview of common practical issues in the conduct of a randomized controlled trial and suitable solutions - is able to design a valid randomized controlled trial for any intervention - is able to read, understand and appraise epidemiological scientific papers on randomized controlled trials |
| Prerequisite knowledge | Introduction to Epidemiology Study Design Clinical Epidemiology (preferred) |
| Course days | Monday, Tuesday, Wednesday, Thursday, Friday |
| Course format | Lectures, practical exercises, seminars |
| Assessment | Daily quiz and group presentations All elements have to be awarded with at least a 5.5 in order to pass the final Assessment. |
| Number of participants | 60 |
| Course fee | € 980,- |
| Prerequisite for participation is sufficiënt capacity in terms of teachers and locations. This course can also be followed online. Look at the website http://elevatehealth.eu/courses for more information and costs. | |
Maximum participants
60
Fee (€)
980.00