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. This online medical 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 provides a thorough medical education into the field of clinical trials, covering 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. The program also touches on the principles of drug risk assessment in the context of therapeutic research.
Course participants will come from pharmaceutical companies, regulatory authorities, health technology assessment bodies, patients’ organizations, consultancy companies and academia. The course will foster discussion, interaction and mutual learning across all professionals involved in medicine development.
By the end of the course, you should be able to:
• Explain the basic design principles of a randomized controlled trial
• Describe specialized design options for a randomized controlled trial
• Apply the basic principles of data analysis of a randomized controlled trial
• Describe the principles of advanced data analysis of a randomized controlled trial
• Explain the principles of drug risk assessment and how to evaluate potential side effects of medication
• State common practical issues in the conduct of a randomized controlled trial and suitable solutions
• Design a valid randomized controlled trial for any intervention
• Interpret scientific papers on randomized controlled trials
This Clinical Trials and Drug Risk Assessment course includes a take-home assignment. The exact deadline for this take-home assignment will be announced as soon as possible.
The take-home assignment is not compulsory. However, if you want to receive the Course Certificate and the credits, it is obligatory to hand in the take-home assignment. You are allowed to redo this once.
When you finished all the exercises of the online course and completed the take-home assignment, you will receive an official Academic Certificate from the Utrecht University.
Utrecht University is a prestigious institution that has been at the forefront of education, research, and innovation since its establishment in 1636.
Utrecht university has been featured prominently in global rankings, highlighting their contributions to various fields of study. Whether it’s their research impact, academic programs, or the quality of their faculty and students, their rankings affirm their dedication to academic success.
In the Shanghai Ranking Utrecht University ranked #1 in the Netherlands. Worldwide Utrecht University ranked #51 (17.000+ universities).
To enrol in this course, you need:
• A BSc or Master’s degree in (Bio)medical or Life Sciences
• Sufficient proficiency in English reading and writing
• Sufficient understanding of epidemiology, statistics and data analysis. Elevate courses offering this knowledge include Introduction to Epidemiology, Study Design in Etiologic Research and Clinical Epidemiology
• Programming skills and knowledge are preferred
We offer discounts for participants from Low- and Lower-middle-income Countries. Utrecht University and UMC Utrecht employees and students are eligible for a 10% discount. Unfortunately, we don’t offer any scholarships.
No, there aren’t any set times you should be online as it is an asynchronous course. All the web lectures are already pre-recorded. However there will be deadlines each week (during the week as well on weekends). Each week consists of approximately 14 study hours. To experience maximum interaction, we advise you to log in several times per week. Furthermore, you should be aware that the teacher and the e-moderator are off on weekends.
No, this is not possible because the course contains group assignments, so you can’t work ahead. Each week, a new learning unit will be made available. This means that not all the learning units are open simultaneously. Additionally, you can’t catch up on the course because there are deadlines to meet every week.
After enrollment, you will receive a confirmation email. A week before the course officially starts, you will receive an email with more detailed information and planning.
If you have ordered a course and paid immediately, you will receive an email with your login details. Sometimes, this email ends up in your spam folder. If you already have an existing account, simply log in to our learning environment. The course you just ordered will be visible in your account.
If you paid by invoice, you will receive your login credentials as soon as the invoice is paid. If the course is starting soon and you haven’t received your login details, please reach out to us at info@elevatehealth.eu to inquire about the payment status.
When you have completed all the assignments or have finished the exam with a good grade, you will receive an official certificate from Utrecht University. All academic certificates issued by Utrecht University will be sent by mail to the address registered in your account. Since these certificates are official documents, they cannot be sent by email.