October 10, 2023
Open to all ISPOR Members and Non-members
Title: External Control Arms - Application, Key Methods, and Acceptability
Tuesday, October 10, 2023
10:00AM EDT | 2:00PM UTC | 4:00PM CEST
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An external control arm (ECA) uses a data source external to the clinical trial, often a real-world data (RWD) cohort, to generate a comparator arm, or to enhance a comparator arm for a clinical trial. ECAs are useful when a fully powered randomized controlled comparator arm is not feasible or unethical. The acceptability of ECAs can differ between regulatory and health technology assessment (HTA) bodies, and guidelines in this area are rapidly evolving. As part of this webinar, Helene Karcher will provide an introduction into what ECAs in the context of Phase 3 programs including an overview of the key challenges when a traditional comparator arm in a randomized control trial is not feasible. Emma Hawe will provide a description of the terminology, and an overview of the key considerations, methodology, and limitations. The webinar will also provide an overview of regulatory and HTA body guidelines and provide an overview of recent acceptability of ECAs. The last 10 minutes will provide the attendees with the opportunity to ask the speakers questions regarding the use of ECAs. This webinar will be of interest to researchers, regulators, payers, and leaders participating in Phase 3 program design and new pharmaceutical product decisions interested in gaining an understanding of ECAs.
Learning Objectives
- Understand when and why external control arms (ECA) are used and what are acceptable types of data and methods to build ECAs
- Understand terminology such as Target Trial Emulation, ECA, historic control arms, simulated and synthetic control arms and be aware of the key considerations when performing ECA, including methods, assumptions and limitations of ECAs
- Understand the circumstances under which ECAs are accepted from regulatory and HTA bodies
Speakers:
Helene Karcher, PhD, Global Head, RWE Ophthalmology, Respiratory & Allergy, Novartis, Basel, Switzerland
Emma Hawe, Head, Data Analytics and Design Strategy, RTI Health Solutions, Manchester, England, UK
Ashley Jaksa, MPH, Market Access Scientific Strategy Lead, Aetion, Boston, MA, USA
Brought to you by: ISPOR Statistical Methods in HEOR Special Interest Group and ISPOR Real-World Evidence Special Interest Group
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.