• Start date:
  • 7 April 2020
  • Duration:
  • 3 days
  • Working as:
  • (Academic) researcher, PhD, Student

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.

The course is coordinated by Nan van Geloven of the department of Biomedical Data Sciences, which also provides support for the practical sessions.
The course will cover 2.5 days and ends the third day at 12.30 hrs.

Course material
All study materials are supplied electronically only. This includes PowerPoint presentations and background materials. Participants are expected to make notes either on their own tablets or laptops or to print out whatever they find convenient to make notes on. The exercises for the practical sessions are also provided in print for your convenience.

Basic knowledge of statistics (equivalent to the Boerhaave course "Basic methods and reasoning in Biostatistics"). A laptop with WiFi connection for all participants is mandatory.

Teaching environment
Lectures and practical sessions.

Exams and certificate of participation 
No exam has to be taken to complete the course. To obtain a certificate of participation, ALL lectures and practical exercise sessions should have been attended. 

Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.

Target group
Master and PhD students; clinical researchers.

Draft program (definitive version will follow)

  Tuesday 7 April 2020
09:00 Registration
09:15 Introduction
09:30 Lecture
10:30 Coffee break
10:45 Lecture
12:00 Lunch break
13:00 Practical exercises
15:00 Coffee break 
15:15 Lecture
16:00 Practical exercises
17:00 Closing
  Wednesday 8 April 2020
09:00 Registration
09:15 Lecture
10:30 Coffee break
11:00 Lecture
12:00 Lunch break
13:00 Practical exercises 
13:45 Lecture 
14:45 Coffee break 
15:00 Practical exercises
16:15 Lecture 
17:00 Closing 
  Thursday 9 April 2020
09:00 Registration
09:15 Lecture
10:15 Coffee break 
10:45 Lecture
11:45 Practical exercises
12:00 Wrap up 
12:15 Closing 


Albinusdreef 2, 2333 ZA Leiden

Building: Gebouw 1 

Room: J1-83

Employees LUMC € 150,00

Non - LUMC participants € 950,00

Participation is free of charge for bachelor and master students of the Leiden University or VU University. Please fill in your student email address and your student number. Please be informed that we can ask you to show your student pass at the registration desk. Please note that a fee will be charged to students who do not attend courses or who are too late cancelling their participation of the course.