Statistical Aspects of Clinical Trials 2026
- Start date:
- 13 April 2026
- Duration:
- 4 days
- Intended Audience:
- Researcher, PhD
Introduction
In this 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.
Course material
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.
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 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.
Teaching environment
Lectures and practical sessions.
Language
Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.
Target group
Master and PhD students (at start PhD; year 1 or 2); clinical researchers.
NOTE: Can only start with sufficient 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.
| CONCEPT 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.
