• Startdatum:
  • 7 april 2025
  • Cursusduur:
  • 3 dagen
  • Werkzaam als:
  • Onderzoeker, PhD

Registration for this course will be possible at the end of October 2024.
If you are interested in this course, we can put you on our mailing list so you will be notified when registration is possible. If so, please send an e-mail to j.j.m.van_der_voet@lumc.nl.

Introduction
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.

Prerequisites
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.

Language
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

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* Interested in another statistics course? Please visit our website to check out the various courses that are offered by Boerhaave Nascholing.

  CONCEPT PROGRAM
Room J1-83, route 555, LUMC
  MONDAY 07 APRIL 2025
09:00 Registration
09:15 Introduction
Dr. ir. Nan van Geloven
09:20 Lecture: Design and analysis of clinical trials 1
Prof. dr. Hein Putter
10:15 Coffee break
10:30 Lecture: Design and analysis of clinical trials 2
Prof. dr. Hein Putter
11:45  Lunch break (lunch not covered)
12:45 Practical exercises: Analysis of a clinical trial (work in pairs or individually)
Dr. ir. Nan van Geloven, E.F. Bonneville
14:45 Discussion exercises: Analysis of a clinical trial
15:00 Lecture: Estimands and sensitivity analyses: ICH E9 Addendum
16:00 Coffee break
16:15 Practical exercise: Estimands (work in pairs or individually)
Dr. ir. Nan van Geloven
16:30 Early phase trials
Dr. Erica Klaassen
17:15 End of day 1
   
  TUESDAY 08 APRIL 2025
09:00 Registration
09:15 Lecture: Sample size calculation
Dr. ir. Nan van Geloven
10:15 Coffee break
10:30 Practical exercise: Sample size calculation
Dr. ir. Nan van Geloven, E.F. Bonneville
11:45 Lunch break (lunch not covered)
12:45 Discussion exercises: Sample size calculation
13:00 Lecture: Missing data in clinical trials
Dr. ir. Nan van Geloven
14:00 Practical exercise: Missing data
Dr. ir. Nan van Geloven
14:15 Lecture: Interim analyses and DSMB
Dr. ir. Nan van Geloven
15:00 Coffee break
15:15 Lecture: Heterogeneity of treatment effect 
Dr. David van Klaveren
16:00 Practical exercise: Heterogeneity of treatment effect (work in pairs or individually)
Dr. David van Klaveren, dr. ir. Nan van Geloven
17:00 Discussion exercise: Heterogeneity of treatment effect 
Dr. David van Klaveren
17:15 End of day 2
  WEDNESDAY 09 APRIL 2025
09:00 Registration
09:15 Lecture: Non‐inferiority design
Dr. ir. Nan van Geloven
10:00 Practical exercise: Non‐inferiority design incl. discussion (work in pairs or individually)
Dr. ir. Nan van Geloven
10:30 Coffee break
10:45 Evaluation
11:00 Lecture: Medical Ethical Committee
Prof. dr. Olaf Dekkers
12:00 Closing
Prof. Dr. O.M. Dekkers
Dr. ir. N. van Geloven
Biostatisticus, LUMC
Dr. D. van Klaveren
Assistant Professor, Erasmus MC
Prof. dr. H. Putter
Hoogleraar, wetenschappelijk staflid, LUMC
LUMC
Albinusdreef 2, 2333 ZA Leiden

Gebouw: Gebouw 1 (Ziekenhuisgebouw)
Zaal: J1-83
Route: 555

Route description to the LUMC and parking

Regular course fee € NTB
Reduced fee for PhD students LUMC  € NTB
Reduced fee for employees LUMC € NTB
BA/MA students of the Leiden University            Free of charge *
BA/MA students of other universities (non Leiden University)    NTB *

* 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 € 50,- cancellation fee will be charged to students who do not attend the course (no show), or cancel their registration. Incomplete registration will not be considered.

Please note that upon registration, you agree to our Terms and Conditions, including the stated cancellation policy. Administration fees may be charged upon cancellation. Moving your registration to the next edition is not possible.