Join us for this event to explore the advantages and challenges of subgroup analysis in early drug development.
Defining patient subgroups more likely to benefit from novel treatments is an increasing imperative in this era of precision medicine. Moreover, an increasingly competitive market space provides further incentive for defining such patient subgroups. Predictive biomarkers play a key role in creating and assessing subgroups, and the very definition of a predictive biomarker is predicated on subgroup analyses demonstrating a statistical interaction between the biomarker level and the treatment effect. Thus, subgroup analyses now play a larger role in drug development, and arguably in earlier stages than in the past.
Early definition of subgroups more likely to benefit often becomes a crossroads leading to higher chance of success and a swifter development if the right subgroup is chosen, but the alternative road entails greater safety by postponing these early choices, albeit at the cost of a slower development. Unfortunately, the well-known risks of false-positive and false-negative findings from subgroup analyses in phase 3 trials are compounded by smaller samples sizes, uncertainties about the analytic performance of the biomarker, and the fact that early-phase trials are often plagued by the phenomenon of “regression to the mean”.
In this presentation, we will attempt to outline the key aspects that need to be taken into account when looking at subgroups in early development. This can hopefully allow for more informed decisions and explicit understanding of potential trade-offs between choices. The main examples will come from the oncology space, but the concepts discussed are applicable to any other indication where precision medicine is of interest.
Key learning objectives:
- Central aspects of subgroup analysis in early drug development
- Potential trade-offs associated with defining patient subgroups
Date: Wednesday, 21st of June, 2023
Time: 9:00 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
|09:00||Networking, registration and light breakfast|
David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
Erik Falvey, Senior Director Business Development Europe, International Drug Development Institute
|09:35||Promise and Perils of Subgroup Analysis in Early Drug Development
Everardo D. Saad, MD, Medical Director, International Drug Development Institute
|11:00||End of Good Morning Meeting|
|Organized by||In collaboration with|