• Start date:
  • 11 April 2023
  • Duration:
  • 3 days
  • Intended Audience:
  • Rsearcher, PhD

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.

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.

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.

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.

Organizing committee

09:00 Registration
09:15 Introduction
09:20 Lecture: Basic and advanced analysis approaches
10:15 Coffee break
10:30 Lecture: Randomization and blinding
11:45  Lunch break
12:45 Practical exercises: analysis of a clinical trial (work in pairs or individually)
14:45 Lecture: Sample size calculation
15:45 Coffee break
16:00 Practical exercises: sample size calculation (work in pairs or individually)
17:15 End of day 1
09:00 Registration
09:15 Lecture: Data management and data quality
10:15 Lecture: Missing data
10:30 Coffee break
10:45 Lecture: Multiple imputation
11:45 Lunch break
12:45 Practical exercise: multiple imputation (work in pairs or individually)
14:00 Lecture: Interim analyses & DSMB
14:50 Coffee break
15:00 Lecture: Heterogeneity of treatment effect + subgroup effects
16:00 Practical exercise: heterogeneity of treatment effect (work in pairs or individually)
17:00 End of day 2
09:00 Registration
09:15 Lecture: Superiority vs non‐inferiority vs equivalence design
10:15 Practical exercise: Non‐inferiority (work in pairs or individually)
11:00 Lecture: Medical Ethical Committee
12:00 Wrap-up
12:30 Closing
Dr. ir. N. van Geloven
Biostatisticus, LUMC
Albinusdreef 2, 2333 ZA Leiden
Regular course fee € 550,-
Reduced fee for PhD students LUMC  € 150,-
Reduced fee for employees LUMC € 150,-
BA/MA students of the Leiden University            Free of charge *
BA/MA students of other universities (non Leiden University)    € 75,-*

* 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 boerhaavenacholing@lumc.nl. Please note that a € 45,- cancellation fee will be charged to students who do not attend the course (no show), or cancel their registration.