PSI Book Club
PSI are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.
This year the PSI Training Committee and the PSI Scientific Committee are delighted to offer 2 pre-conference courses. Both of these courses will run on the afternoon of Sunday 12th June and will be held at the same location used for the conference itself – at the Gothia Towers in Gothenburg. Both courses will be available for registration through the main conference registration portal, so please sign up when you register for the conference itself to avoid disappointment!
Both courses will run on Sunday 12 June 13:00 - 17:00 at Gothia Towers.
Estimand-aligned statistical analyses of clinical trial
Defining the scientific questions of interest in a clinical trial is crucial to align its design, conduct, analysis, and interpretation. With the recent release of an addendum to the E9 guideline on 'Statistical principles in clinical trials' by the International Council of Harmonization (ICH), regulatory agencies require statistical analyses to be aligned with the target estimand(s) which precisely describe the treatment effect(s) of interest that a clinical trial should address.
For a given estimand, an aligned method of analysis, or estimator, should be implemented that is able to provide an estimate on which reliable interpretation can be based and which includes the handling of post-randomization events, missing data and sensitivity analyses. Many statistical analysis procedures are available for different types of data, although it is often unclear which estimands these imply.
In this course, we first briefly introduce the ICH E9 addendum on estimands. We then discuss how to identify and implement analyses approaches as well as sensitivity analyses that are aligned with a chosen estimand for different types of endpoints (continuous, binary, time-to-event, recurrent events) in longitudinal clinical trial settings. We illustrate the methods with real case studies and provide code examples to facilitate implementation in practice.
Presented by Dominic Magirr and Björn Bornkamp
A practical introduction to simulating complex trial designs.
Complex trials present their own set of challenges at the design stage. In some cases this complexity requires the use of simulation in order to understand the operating characteristics of the design. Indeed simulation can be a powerful tool, allowing many questions to be answered about how a design will perform.
In this course we shall learn how to use R to construct simulation studies that allow us to evaluate the potential of complex designs. In addition to informing the design of the trial, we will show how simulations can allow the investigation of the impact of deviations from the pre-planned trial design (such as slow patient accrual). Further to this we shall discover the totality of information available from simulation and the breadth of understanding available from such techniques.
Presented by Thomas Burnett and Thomas Jaki
Participants are encouraged to bring a laptop with R installed to be able to make the most of this training.
The registration fees for the pre conference courses are as follows.
|Registration Item||Early Bird Rate||Standard Rate|
All amounts are in SEK and include local VAT.