• Start date:
  • 6 April 2021
  • Duration:
  • 3 days
  • Working as:
  • 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.

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.

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 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. 

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

Target group
Master and PhD students; clinical researchers.

  FINAL PROGRAM
  Tuesday 6 April 2021
09:00 Log-in
09:15 Introduction
09:30 Lecture: Design and analysis of clinical trials 1
10:30 Coffee break
10:45 Lecture: Design and analysis of clinical trials 2
12:00 Practical exercises: analysis of a clinical trial (break-out rooms in Zoom / work individually)
14:45 Discussion exercises
15:00 Lecture: Sample size calculation
16:00 Practical exercises: sample size calculation (break-out rooms in Zoom / work individually)
16:45 Discussion excercises
17:30 End of day 1
   
  Wednesday 7 April 2021
09:00 Log-in
09:15 Lecture: Data management and data quality
10:00 Lecture: Missing data
10:30 Coffee break
10:45 Lecture: Multiple imputation
11:45 Practical exercise: multiple imputation (break-out rooms in Zoom / work individually)
13:45 Discussion exercise
14:00 Lecture: Medical Ethical Committee
14:50 Coffee break
15:00 Lecture: Heterogeneity of treatment effect + subgroup effects
16:00 Practical exercise: heterogeneity of treatment effect (break-out rooms in Zoom / work individually)
16:45 Discussion exercises
17:00 End of day 2
   
  Thursday 8 April 2021
09:00 Log-in
09:15 Lecture: Superiority vs non‐inferiority vs equivalence design
10:15 Practical exercise: non‐inferiority (break-out rooms in Zoom / work individually)
10:50 Discussion exercise
11:00 Lecture: DSMB and stopping rules
12:00 Wrap-up
12:30 Closing
Dr. ir. N. van Geloven
Biostatisticus, LUMC
Dr. van Klaveren
Assistant Professor, Erasmus MC
I. Prosepe
Onderzoeker in opleiding
H. Putter
Hoogleraar, wetenschappelijk staflid, LUMC
Dr. K. Schaap
Specialist medical research data management, LUMC
Em. prof. T. Stijnen
Online
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Regular course fee € 450,-
Reduced fee for PhD students LUMC  € 150,-
Reduced fee for employees LUMC € 150,-
BA/MA students of the Leiden University         Free of charge *
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.