With fewer than 10% of compounds successfully achieving Phase 1 to FDA approval status1, researchers are increasingly seeking data and methods to address key challenges. Historical clinical trial and real-world datasets have emerged as attractive options to power synthetic controls that can aid in trial design, replacement/augmentation of control groups, identifying differentiation in treatment effects across subpopulations and discovery of endpoint correlations.As promising as these can be, the nuances and implications need to be well understood in a heavily regulated industry.In this 1-hour session, you will hear from former FDA leaders and industry experts who will address:
- What is a Synthetic Control and how can it be leveraged in clinical development?
- What makes for a “good” dataset when building a Synthetic Control?
- What are the different types of methods utilized?
- What is the regulatory perspective on the evolution and adoption of synthetic controls?
- Has there been a historical usage of synthetic controls in pharma?
- Where are they seeing the application of synthetic controls take place?
1Source: Clinical Development Succes Rates 2006-2015, BIO Biomedtracker, Amplion