05/18/2026
Bernat Navarro, Senior Science Policy Analyst, will be presenting findings from the Friends of Cancer Research ECA Pilot Project at ISPOR—The Professional Society for Health Economics and Outcomes Research in Philadelphia on Wednesday, May 20 at 9:00AM ET.
External control arms (ECAs) can support evidence generation in oncology settings where randomized trials are infeasible, inefficient, or difficult to conduct. However, confidence in ECAs depends on whether external data sources can reliably identify patients comparable to a target clinical trial population and whether differences in data capture, missingness, and analytic interpretation are well understood.
In the ECA Pilot Project, nine data partners applied shared statistical analysis plan to examine how ECAs could be constructed across heterogeneous external data sources to approximate the control arm of the RESOLVE randomized clinical trial in metastatic pancreatic ductal adenocarcinoma. Preliminary findings showed that independent ECA construction was feasible under this shared framework, while highlighting how eligibility implementation, data availability, missingness, and analytic choices can influence cohort composition, baseline comparability, and outcome estimates. These findings reinforce the importance of transparent documentation when assessing whether the underlying data are fit-for-purpose for ECA construction.
Take a closer look at the findings from our ECA Pilot Project and view the full poster here: https://bit.ly/4eZ3Bvz.
Thank you to the data partners, co-authors, and ECA Pilot Project working group members for their time and contributions.
Data partners: ConcertAI, COTA + Verana Health, Flatiron Health, Guardian Research Network/IQVIA, iOMEDICO, Medidata Solutions, Ontada, Pancreatic Cancer Action Network, and Tempus AI
Authors: Bernat Navarro, Ph.D., Kawther Abdilleh, Ph.D., Amy Alabaster, MPH, Peter Ansell, Ph.D., Li Chen, Ph.D., Gregory S. Calip, MPH, PharmD, Ph.D., Ruthi Davi, Ph.D., Janet Espirito, PharmD, Laura L. Fernandes, Ph.D., Sebastian Zavala Hoffmann, MS, Patricia Luhn, Ph.D., Xinran Ma, MS, Patricia Prince, MPH, Mark Riffon, MPH, Xiang Yin, Ph.D., Mark Stewart, Ph.D., Hillary Andrews, Ph.D., Jeff Allen, Ph.D.
