ONLINE - Statistical Aspects of Clinical Trials 2021
- Start date:
- 6 April 2021
- 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 PowerPoint presentations and background materials. Participants are expected to make notes either on their own tablets or laptops or to print out whatever they find convenient to make notes on.
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 have been attended.
Course material (PowerPoint, exercises etc.) are all in English. Lectures are also in English.
Master and PhD students; clinical researchers.
|Tuesday 6 April 2021|
|09:30||Lecture: Design and analysis of clinical trials 1|
|10:45||Lecture: Design and analysis of clinical trials 2|
|12:00||Practical exercises: analysis of a clinical trial (break-out rooms in Zoom / work individually)|
|15:00||Lecture: Sample size calculation|
|16:00||Practical exercises: sample size calculation (break-out rooms in Zoom / work individually)|
|17:30||End of day 1|
|Wednesday 7 April 2021|
|09:15||Lecture: Data management and data quality|
|10:00||Lecture: Missing data|
|10:45||Lecture: Multiple imputation|
|11:45||Practical exercise: multiple imputation (break-out rooms in Zoom / work individually)|
|14:00||Lecture: Medical Ethical Committee|
|15:00||Lecture: Heterogeneity of treatment effect + subgroup effects|
|16:00||Practical exercise: heterogeneity of treatment effect (break-out rooms in Zoom / work individually)|
|17:00||End of day 2|
|Thursday 8 April 2021|
|09:15||Lecture: Superiority vs non‐inferiority vs equivalence design|
|10:15||Practical exercise: non‐inferiority (break-out rooms in Zoom / work individually)|
|11:00||Lecture: DSMB and stopping rules|
|Regular course fee||€ 450,-|
|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.