November 18, 2021
Sponsored by Certara Evidence and Access
Open to all ISPOR Members and Non-members
- Sumeet Bakshi. PhD, MBA
- Artak Khachatryan, PhD
November 18, 2021
10:00AM EST | 3:00PM GMT | 4:00PM CET
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Both the FDA and EMA have made statements that support the concept of using real world evidence (RWE) for regulatory decision-making. Historical control arms represent a way to take a safe and effective leap forward into real-world evidence. But there is much heterogeneity in the lexicon (eg. external, historical, synthetic) and the tools used (eg. natural history cohorts, disease registries, placebo arms of clinical trials, simulated cohorts, artificial intelligence). During this presentation, the speakers will present a case for a common language and the need for a robust toolkit that supports planning and design of external control arms.
- The context for external control arms - regulatory/HTA
- A discussion of key terms related to external control arms and available tools
- Key design considerations for external control arms and suggestions to harmonize/clarify language and methods
- Demonstrate a “toolkit” approach with the use of case studies
Sponsored by: Certara
Sumeet Bakshi, PhD, MBA, VP, Real World Data Solutions, Certara, London, UK
Artak Khachatryan, PhD, Senior Director, Pharmaco-Epidemiology, Certara, London, UK
Please note: On the day of the scheduled HEOR Theater, the first 1000 registered participants will be accepted. For those who are unable to attend, or would like to review the HEOR Theater On-Demand at a later date, please register using the link above to access the full-length recording.
Reservations are on a first-come, first-served basis.