Statistical Aspects of Clinical Trials 2026
- Start date:
- 13 April 2026
- Duration:
- 4 days
- Intended Audience:
- Researcher, PhD
Introduction
Are you designing or analyzing data from a clinical trial? Want to broaden your statistical knowledge? Then register for our ‘Statistical Aspects 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.
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.
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.
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.
Organizing committee
Dr. ir. Nan van Geloven (N.van_Geloven@lumc.nl)
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* Interested in another statistics course? Please visit our website to check out the various courses that are offered by Boerhaave Nascholing.
| PROGRAM CZ-7, route 555, LUMC | |
| MONDAY 13 APRIL 2026 | |
| 09:00 | Registration |
| 09:10 | Introduction Dr. ir. Nan van Geloven |
| 09:15 | Lecture: Design and analysis of clinical trials 1 Prof. dr. Hein Putter |
| 10:15 | Coffee break |
| 10:30 | Lecture: Design and analysis of clinical trials 2 Prof. dr. Hein Putter |
| 11:45 | Lunch break (lunch not covered) |
| 12:45 | Practical exercises: Trial analysis Youngxi Long |
| 14:45 | Discussion exercises: Trial analysis Dr. ir. Nan van Geloven, Youngxi Long |
| 15:00 | Lecture: Estimands and sensitivity analyses: ICH E9 Addendum Dr. Doranne Thomassen |
| 16:00 | Coffee break |
| 16:15 | Practical exercise: Estimands Dr. ir. Nan van Geloven, dr. Doranne Thomassen |
| 16:30 | Lecture: Sample Size calculation Dr. ir. Nan van Geloven |
| 17:15 | End of day 1 |
| TUESDAY 14 APRIL 2026 | |
| 09:00 | Registration |
| 09:15 | Lecture: A meta look on clinical trials Dr. Erik van Zwet |
| 10:15 | Coffee break |
| 10:30 | Practical exercise: Sample size calculation Yongxi Long |
| 11:45 | Lunch break (lunch not covered) |
| 12:45 | Discussion exercises: Sample size calculation Dr. ir. Nan van Geloven, Youngxi Long |
| 13:00 | Lecture: Missing data in clinical trials Dr. ir. Nan van Geloven |
| 14:00 | Practical exercise: Missing data Dr. ir. Nan van Geloven |
| 14:15 | Lecture: Interim analyses and DSMB Dr. ir. Nan van Geloven |
| 15:00 | Coffee break |
| 15:15 | Lecture: Heterogeneity of treatment effect |
| 16:00 | Practical exercise: Heterogeneity of treatment effect |
| 17:00 | Discussion exercise: Heterogeneity of treatment effect |
| 17:15 | End of day 2 |
WEDNESDAY 15 APRIL 2026 | |
| all day | Self study |
| THURSDAY 16 APRIL 2026 | |
| 09:00 | Registration |
| 09:15 | Lecture: Non-inferiority studies Dr. ir. Nan van Geloven |
| 10:00 | Practical exercises: Non-inferiority incl. discussion Dr. ir. Nan van Geloven |
| 10:30 | Coffee break |
| 10:45 | Lecture: Medical Ethical Committee Prof. dr. Olaf Dekkers |
| 11:45 | Evaluation Dr. ir. Nan van Geloven |
| 12:00 | End of course |
LUMC
,* Limited places available. In order to validate your student registration, you must register with your student e-mail address and submit your student number on the registration form. In addition, a scan of your student pass will have to be submitted to boerhaavenascholing@lumc.nl. Incomplete registration will not be considered. Please note that a cancellation fee will be charged to students who do not attend the course (no show), or cancel their registration.
Please note that upon registration, you agree to our Terms and Conditions, including the stated cancellation policy. Administration fees may be charged upon cancellation.
Moving your registration to the next edition is not possible.
