Statistical Aspects of Clinical Trials 2023
- 11 april 2023
- 3 dagen
- Werkzaam als:
- Onderzoeker, PhD
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.
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.
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.
Lectures and practical sessions.
Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.
Master and PhD students (at start PhD; year 1 or 2); clinical researchers.
- Dr. ir. Nan van Geloven (N.van_Geloven@lumc.nl)
|TUESDAY 11 APRIL 2023|
|09:20||Lecture: Basic and advanced analysis approaches|
|10:30||Lecture: Randomization and blinding|
|12:45||Practical exercises: analysis of a clinical trial (work in pairs or individually)|
|14:45||Lecture: Sample size calculation|
|16:00||Practical exercises: sample size calculation (work in pairs or individually)|
|17:15||End of day 1|
|WEDNESDAY 12 APRIL 2023|
|09:15||Lecture: Data management and data quality|
|10:15||Lecture: Missing data|
|10:45||Lecture: Multiple imputation|
|12:45||Practical exercise: multiple imputation (work in pairs or individually)|
|14:00||Lecture: Interim analyses & DSMB|
|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|
|THURSDAY 13 APRIL 2023|
|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|
LUMCAlbinusdreef 2, 2333 ZA Leiden
|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 email@example.com. Please note that a € 45,- cancellation fee will be charged to students who do not attend the course (no show), or cancel their registration.