Statistical Aspects of Clinical Trials

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, flexible designs (interim analyses and stopping rules) 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 Medical Statistics and Bioinformatics (LUMC), which also provides support for the practical sessions.
The course will cover 2.5 days and ends the third day at 13.00 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 two afternoon sessions are also provided in print for your convenience.

Prerequisites
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
None (to obtain a certificate of participation, lectures should have been attended and special practical exercises should have been submitted).

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

Target group
Master and PhD students; clinical researchers.

Monday 9 April 2018

08:30	Registration
09:00	lectures
10:15	Coffee break
10:30	lectures
11:30	Lunch break
12.30	lectures
14:30	Coffee break
14:45 - 17.00	Practical exercises

Tuesday 10 April 2018

08:45	Registration
09:00	lectures
10:15	Coffee break
10.30	lectures
11:15	Coffee break
11:30	lectures
12:15	Lunch break
13:15	lectures
14:00 - 17.00	Practical session

Wednesday 11 April 2018

08:45	Registration
09:00	lectures
10:15	Coffee break
10.30	lectures
+/- 11.45	End of course

 

LUMC

Hippocratespad 21, 2333 ZD Leiden

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.