Design and Analysis of Clinical Trials
Learn practical statistical methods for designing, analysing and interpreting clinical trials.
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General information
Introduction
Are you designing or analyzing data from a clinical trial? Want to broaden your statistical knowledge? Then register for our ‘Design and Analysis of Clinical Trials’ course to learn state-of-the-art techniques and get practice tips from experts. Topics include randomization and blinding, endpoints and analysis, sample size calculation, estimands and intercurrent events, missing data, data safety monitoring boards, heterogeneity of treatment effect, non-inferiority design and reflection on the IRB approval process. Practical sessions will focus on hands-on experience in the above topics, based on an example trial dataset.
Course material
Slides and background materials will be shared electronically. All materials will be made available in an online learning environment to which students receive access about 2 weeks 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. You will be asked to hand-in answers to open-ended questions from the practical exercises on padlet.
Teaching environment
Lectures, practical sessions and group discussions.
Language
Course material (slides, exercises etc.) are all in English. Lectures are also in English.
Learning objectives
Target group
PhD students (preferably at start of your PhD; year 1 or 2) and clinical researchers; interested master students are also welcome.
NOTE: The course will only run with sufficient number of participants.
Study load / preparation
Prerequisites
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 SPSS or R software installed, and a notebook for taking written notes (if desired). For the practical exercises on day 1 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.
Programme
Location
LUMC
Albinusdreef 2
2333 ZA Leiden
Building: Gebouw 1
Route: 555
Room: Collegezaal-7
Leids Universitair Medisch Centrum
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LUMC, Albinusdreef 2, 2333 ZA Leiden Building: Gebouw 1 Route: 555 Room: Collegezaal-7