External Control Arm (ECA) in Oncology Studies

• Activity Number: 12 - Opportunities and Challenges in the Use of External Control Arms in Drug Development
• Type: Invited
• Date/Time: Sunday, August 7, 2022 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Helen Zhou* and Antara Majumdar and Andrew Smith and Brielle Forsthoffer and Nicky Best and Tai-Tsang Chen
• Companies: GSK and GSK and GSK and GSK and GSK and GSK
• Keywords: ECA; Data Augmentation; Oncology; Innovative Clinical Trials; Data Strategy

Abstract

ECA based innovative clinical study designs can be valuable in accelerating all phases of Oncology drug development. Significant organizational investment would be required towards building up the ECA capability needed for a seamless execution of an ECA based design. These ECA capabilities encompass data strategy, data science, technology, and statistical methodology. This, in turn requires strong cross functional collaboration among statistics, clinical, programming, epidemiology, data science and regulatory groups.

This presentation will review some of the key opportunities and challenges in this regard through a case study in non-small cell lung cancer (NSCLC). We will share some recent GSK experiences with external data acquisition, cross-linking, harmonization, and statistical analysis of an ECA/hybrid ECA based study.