Can External Control Arms Address Regulator and HTA Evidence Requirements in a 'Learning System'?


March 30, 2021

Virtual |


The breadth and depth of real-world data today may offer an opportunity to understand patient care and outcomes with more clarity than randomized clinical trials can bring. Study designs are evolving, with external controls playing an increasingly important role in product evaluation, but questions remain around accepted evidentiary standards. Both regulatory and HTA decision-makers are evolving their decision paradigms to fulfill the promise of RWE. This panel discussion will include a lively discussion of:

  • Ways to create a ‘learning decision-making system’ that integrates multiple and disparate data models to support decision
  • How regulators and payers view external control arms
  • Takeaways from pioneering efforts to incorporate learning from the complete patient experience as input for overcoming approval and access barriers




We are always available for a conversation.


We are always available for a conversation.


Communication Preference

Communication Preference