Statistical Aspects of Clinical Trials 2023
- Startdatum:
- 11 april 2023
- Cursusduur:
- 3 dagen
- Werkzaam als:
- PhD
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
- Dr. ir. Nan van Geloven (N.van_Geloven@lumc.nl)
| TUESDAY 11 APRIL 2023 | |
| 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 |
| 12:45 | Practical exercise: Analysis of a clinical trial (work in pairs or individually) Dr. ir. Nan van Geloven, Ms.Ilaria Prosepe |
| 14:45 | Lecture: Sample size calculation Dr. ir. Nan van Geloven |
| 15:45 | Coffee break |
| 16:00 | Practical exercise: sample size calculation (work in pairs or individually) Dr. ir. Nan van Geloven, Ms.Ilaria Prosepe |
| 17:15 | End of day 1 |
| WEDNESDAY 12 APRIL 2023 | |
| 09:00 | Registration |
| 09:15 | Lecture: Missing data and multiple imputation in clinical trials 1 Dr. ir. Nan van Geloven |
| 10:00 | Coffee break |
| 10:15 | Lecture: Missing data and multiple imputation in clinical trials 2 Dr. ir. Nan van Geloven |
| 11:00 | Practical exercise: Multiple imputation (work in pairs or individually) Dr. ir. Nan van Geloven, Ms.Ilaria Prosepe |
| 12:15 | Lunch break |
| 13:15 | Lecture: Estimands and sensitivity analyses: ICH E9 Addendum Dr. ir. Nan van Geloven |
| 14:00 | Lecture: Interim analyses and DSMB Dr. ir. Nan van Geloven |
| 14:45 | Coffee break |
| 15:00 | 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 | End of day 2 |
| THURSDAY 13 APRIL 2023 | |
| 09:00 | Registration |
| 09:15 | Lecture: Non‐inferiority design Dr. ir. Nan van Geloven |
| 10:15 | Practical exercise: Non‐inferiority design (work in pairs or individually) Dr. ir. Nan van Geloven |
| 11:00 | Lecture: Medical Ethical Committee Prof. dr. Olaf Dekkers |
| 12:00 | Wrap-up |
| 12:30 | Closing |
| Regular course fee | € 550,- |
| 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.
