Statistical Aspects of Clinical Trials 2022
- Start date:
- 11 April 2022
- 3 days
- Intended Audience:
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.
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).
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.
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.
Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.
Master and PhD students; clinical researchers.
|MONDAY 11 APRIL 2022|
|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|
|Tuesday 12 April 2022|
|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|
|WEDNESDAY 13 APRIL 2022|
|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||€ 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 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.