Advanced Clinical Trial Design

Course 6

Date

23 – 25 January 2025

Faculty

PD Dr. Sven Trelle
Clinical Trials Unit, University of Bern, Switzerland

Prof. James Wason
Newcastle University, United Kingdom

Venue

CH – 3823 Wengen | tba

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, 23 January 8:00 am – 12:00 pm | 4:30 pm – 6:30 pm

  • Adaptive trials
  • Multi-arm, platform and precision medicine trials
  • Outcomes and estimands
  • Sequential multiple assignment randomized trials

Friday, 24 January 8:00 am – 12:00 pm | 4:30 pm – 6:30 pm

  • Sample size calculation (basics)
  • Non-inferiority trials
  • Multiple testing

Saturday, 25 January 8:00 am – 12:00 pm | 1:00 pm – 3:00 pm

  • 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. Prior to the course, we will provide instructions regarding the installation of the software packages to be used in the course. All practicals will be supported in R (http://www.r-project.org/) and Shiny Apps web-interfaces. Some practicals will additionally be supported in Stata. A course license for Stata® will be available to install before arrival if required.

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

The pre-registration starts 26 August 12:00 pm until 1 September 12:00 am.
The open registration starts some time in September, the exact date will be communicated. Go to registration

Accomodation

Book your accommodation separately. Please see recommendations for special prices.