Study design from a statistician’s perspective
Course details
Course duration: 4 hours
Target audience: Physicians, medical advisors, scientific researchers, representatives of pharmaceutical companies, project managers
Course dates: Dates for 2025 have not yet been announced
Course fee (excl. VAT): CZK 3,900 per person
Course time and venue: 09:00 – 13:00 at the company headquarters – Poštovská 3, Brno
The course will take place if at least 3 participants register. If the minimum number is not met, we will inform registered participants about the course cancellation three weeks prior to the planned start date.
Course introduction
Designing a clinical study is not just about careful planning, but also about choosing the right study design, setting up appropriate randomization, determining the required sample size… in short, a number of statistical aspects that ensure your study results will be reliable and meaningful. How and why? You’ll find out in this course.
What to expect
Participants of the course “Study Design from a Statistician’s Perspective” will look at study planning through the eyes of a statistician. They will learn how to define clear study objectives, determine the optimal sample size, understand what randomization means, and what must be considered during planning to ensure the study has real interpretative value.
Course objective
The aim of this course is to introduce participants to the principles of statistical thinking in clinical study planning – from setting objectives and randomization to sample size calculation and planning of interim and final analyses.
The course is intended for healthcare professionals actively involved in the preparation of randomized clinical trials (RCTs) as well as non-interventional studies (NIS). The goal of the course is to introduce participants to the basic types of study designs and the key aspects to consider when planning a study: selecting the study population, defining objectives, choosing a design, estimating sample size, and selecting appropriate evaluation methodology.
Whether you’re just starting with study design or already have experience, this course offers plenty of useful tips and tools for your future work.
This intensive course on “clinical trial statistics” is divided into two modules: theoretical and practical. Both parts are designed to complement each other, be interactive, and allow direct application of the acquired knowledge.
The course begins with key biostatistics principles that must be considered when designing, evaluating, and interpreting studies. We then continue with the classification of studies based on different criteria and discuss how they differ methodologically. We clarify why randomization is crucial in some studies and what alternative methods can be used when the study is not randomized. In the second part of the course, we will focus on defining study objectives, calculating sample size, and setting parameters for superiority or non-inferiority. Finally, we will explain what to watch out for when analyzing subgroups.
The topics of the two modules include:
- Introduction to studies
- Key principles of biostatistics – bias, comparability, representativeness, significance, and reliability
- Types of studies
- Study design
- Randomization and propensity score matching
Statistical evaluation of studies:
- Clinical hypotheses and sample size optimization
- Endpoints in studies, superiority, non-inferiority, equivalence
- Subgroup analysis
- Interim analysis
Reference
Interested?
Are you interested in the course or training, but no dates are currently available, the listed date or format doesn’t suit you, or would you like to arrange training for a larger group? Don’t hesitate to contact us at info@biostatistika.cz – we’ll do our best to accommodate your needs.