25 January 2020
Advanced Clinical Trial Design
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, pragmatic trials including routine-data supported or registry trials, cluster-randomized trials, non-inferiority (combined with superiority) study questions, multi-arm versus sequential multiple assignment randomized trials, studies within a trial (SWATs), and estimands. The faculty reserves the right to change focus regarding some of the topics based on developments over the coming months.
Course leader
PD Dr. Sven Trelle CTU Bern, University of Bern, Switzerland
Prof. Matthias Briel Department of Clinical Research, University of Basel, Switzerland
Target group
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.
Students should bring their own portable computers. A course license for Stata® will be available, to be installed before arrival. University of Bern IT staff onsite can provide help upon request per e-mail (it@ispm.unibe.ch)
Course aim
By the end of this course participants will have:
- An understanding of the concept of platform trials
- An understanding of what constitutes a pragmatic trial and how it differs from an efficacy trial
- An understanding of the potential and limitations of routinely-collected data for randomized trials
- 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 the concept and value of SWATs
- An understanding of different estimands and the implications for trial planning
Fee info
CHF 900: SSPH+ students: CHF 700
Academic: CHF 900
Industry: CHF 2000
Participants must book their accommodations themselves. Please see our recommendations on www.epi-winterschool.org/hotels for special prices.
You can register on the Winter School website www.epi-winterschool.org.