Can Synthetic Control Arms Address Regulator and HTA Evidence Requirements?

Register free: https://www.pharmexec.com/pe_w/learning_system ​​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

Event Overview:

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 decisions
• 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

Key Learning Objectives:

• Explore common perceptions surrounding the use of external control arms when randomized trials are unfeasible or unethical
• Understand the various circumstances and practices that influence the viability of single arm trials paired with external control arms
• Learn the principles of framing an approach for gathering real-world data, and the value of partnering with a quantitative strategist on your design

Sponsor: Parexel

Time and Date: Tuesday, March 30, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Mar. 30, 2022

Register free: https://www.pharmexec.com/pe_w/learning_system ​​ ​ ​ ​ ​ ​