Abstract: In the early phases of clinical development, the future of a compound depends on more than just the result of hypothesis test on a single endpoint, in a single phase 2 study. We think a lot about how design choices affect immediate outcomes. GSK's Quantitative Decision Making (QDM) framework focusses on the question,"How do we design our study in order to increase the chances that it will deliver data that will allow us to decide whether the drug should continue in development, or stop?" The QDM Framework has been developed in R and takes advantage of the Biostatistics HPC environment, running thousands of hypothetical scenarios in close to real-time. The initiative is changing the way we plan and deliver clinical trials. Thanks to a Shiny front end, Statisticians are able to walk clinical teams through key trial design decisions in order to estimate the Probability of Success â€“ a key component in the QDM framework. This presentation will cover the core QDM concepts and present the key communication outputs created to support the process.
Speaker: Andy Nicholls
Affiliation: Glaxosmithkline
Title: Making Better Decisions
Abstract_Sanitzed: In the early phases of clinical development, the future of a compound depends on more than just the result of hypothesis test on a single endpoint, in a single phase 2 study. We think a lot about how design choices affect immediate outcomes. GSK's Quantitative Decision Making (QDM) framework focusses on the question,"How do we design our study in order to increase the chances that it will deliver data that will allow us to decide whether the drug should continue in development, or stop?" The QDM Framework has been developed in R and takes advantage of the Biostatistics HPC environment, running thousands of hypothetical scenarios in close to real-time. The initiative is changing the way we plan and deliver clinical trials. Thanks to a Shiny front end, Statisticians are able to walk clinical teams through key trial design decisions in order to estimate the Probability of Success â€“ a key component in the QDM framework. This presentation will cover the core QDM concepts and present the key communication outputs created to support the process.