Advanced Clinical Trial Designs
Course 7
Date
18–20 January 2024
Faculty
PD Dr. Sven Trelle
Clinical Trials Unit, University of Bern, Switzerland
Prof. James Wason
Newcastle University, United Kingdom
Venue
CH – 3823 Wengen | Schule Wengen
Course description
This course will provide an introduction to advanced topics of clinical trial design. The focus will be on trial planning especially sample-size calculations within a hypothesis testing framework and implications for study design. Topics are selected based on practical experience of the faculty and relevance over recent years. In the course we will cover platform trials, multi-arm, sequential multiple assignment randomized trials, cluster-randomized trials, non-inferiority (combined with superiority) study questions, Bayesian trials, adaptive designs, trials for precision medicine, and estimands. The faculty reserves the right to change focus regarding some of the topics based on developments over the coming months.
Course objectives
By the end of this course participants will have:
- An understanding of the concept of platform trials
- An understanding of the principles of adaptive trial designs
- An understanding of the specifics of non-inferiority and cluster-randomized trials
- An understanding of trial designs that aim to test multiple hypotheses
- An understanding of the implications of these design choices on sample-size calculation and how to perform them in practice
- An understanding of different estimands and the implications for trial planning
Course audience
Clinical researchers, (clinical) epidemiologists, medical statisticians, or any research stakeholder with an interest in trial methodology. Participants should have some experience with developing and conducting randomized clinical trials in their professional role.
Course outline
The course runs over three days and consists of lectures, group work, and computer practical sessions. We will also have the opportunity to discuss projects of participants.
We start early in the morning by reviewing the previous day. During extended afternoon breaks, participants review course materials, catch up on email, or ski. We reconvene at 4:30 pm for computer practical sessions.
Thursday, 18 January 8:00 am – 12:00 pm | 4:30 pm – 6:30 pm
Friday, 19 January 8:00 am – 12:00 pm | 4:30 pm – 6:30 pm
Saturday, 20 January 8:00 am – 12:00 pm | 1:00 pm – 3:00 pm
Day 1
- Adaptive trials
- Multi-arm, platform and precision medicine trials
- Outcomes and estimands
- Sequential multiple assignment randomized trials
Day 2
- Sample size calculation (basics)
- Non-inferiority trials
- Multiple testing
Day 3
- Cluster-randomized trials
- Bayesian trials
- Sample size calculation (advanced)
- Clinical trials for precision medicine
Credits
1.0 ECTS
Course materials
Students should bring their own portable computers. A course license for Stata® will be available to install before arrival.
Onsite University of Bern IT staff provides support upon e-mail () request.
Course fee
PhD Bern: CHF 600
PhD other: CHF 800
Academic: CHF 1000
Industry: CHF 2000
Registration
Accomodation
Book your accommodation separately. Please see recommendations for special prices.