• Startdatum:
  • 11 april 2022
  • Cursusduur:
  • 3 dagen
  • Werkzaam als:
  • 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 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. Participants are expected to bring their own laptop for the practical exercies, and a notebook for taking written notes (if desired).

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 be attended.

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

Target group
Master and PhD students; clinical researchers.

  MONDAY 11 APRIL 2022
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
   
  Tuesday 12 April 2022
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
  WEDNESDAY 13 APRIL 2022
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
Prof. dr. O.M. Dekkers
Hoogleraar Endocrinologie, LUMC
Dr. ir. N. van Geloven
Biostatisticus, LUMC
Dr. D. van Klaveren
Assistant Professor, Erasmus MC
I. Prosepe
Onderzoeker in opleiding
Prof. dr. H. Putter
Hoogleraar, wetenschappelijk staflid, LUMC
Dr. K. Schaap
Specialist medical research data management, LUMC
LUMC
Albinusdreef 2, 2333 ZA Leiden

LUMC
Gebouw: 1
Zaal: J1-83

Parkeren en bereikbaarheid LUMC

Regular course fee € 950,-
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.