Statistical Aspects of Clinical Trials 2023
In this 2,5 day course, the design and analysis of clinical trials will be considered from a biostatistical/methodological perspective. Topics include Phase II / Phase III studies, randomization and blinding, power calculations (sample size), analysis of trial outcomes, superiority, inferiority and equivalence, missing values and multiple imputation. Practical sessions will focus on hands-on experience in the above topics, based on an example trial dataset.
All study materials are supplied electronically only. This includes the PowerPoint presentations and background materials. All materials will be made available in an online learning environment to which students receive access about 2 weeks prior to the course.
Basic knowledge of statistics (equivalent to the Boerhaave course "Basic methods and reasoning in Biostatistics").
Participants are expected to bring their own laptop for the practical exercies, with either the SPSS or R software installed, and a notebook for taking written notes (if desired). For the practical exercises you will be asked to download and install the program “Power and sample size calculation” (https://biostat.app.vumc.org/wiki/Main/PowerSampleSize ) prior to the course.
Attendance / Certificate of Attendance
In order to obtain a certificate of attendance, participation in all lectures and practical exercises is mandatory. Completion of practical exercises will be checked by open-ended questions to be submitted on padlet.
Lectures and practical sessions.
Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.
Master and PhD students (at start PhD; year 1 or 2); clinical researchers.
- Dr. ir. Nan van Geloven (N.van_Geloven@lumc.nl)
- Route description to the LUMC and parking