Application and Implementation of Methodologies in Statistics (AIMS)
The AIMS SIG will demonstrate using R for regulatory work in pharmaceutical research. The session will include case studies demonstrating challenges and possible solutions, ranging from implementation of a full R platform to using R for a single piece of work.
The Data Sharing SIG will focus on synthetic data. The session will cover the following topics...
• Overview of synthetic data - what it is and where it could be used
• How synthetic data can be produced
• Examples where synthetic data has been used
Real World Data
The Real World Data SIG aims to increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data (RWD) in the pharmaceutical industry. The agenda for this session includes an orientation into the why, what, who and how of RWD and the evidence that can be generated. Speakers will also cover challenges in “Leveraging Real-World Data for Time-to-Event Endpoints”.
The SIG will be delivering a two part session. The first part will cover Bayes in a nutshell, Bayesian Dynamic Borrowing (BDB) with a focus on robust meta-analytic predictive priors, and discuss a framework for evaluating pivotal BDB designs. In the second part participants will break out in smaller teams and work on a case study to assess which aspects of the study design should be presented and eventually be discussed with regulators, and how the proposed framework presented in part 1 can help to structure this discussion in a systematic way.