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Remote endpoints for clinical trials in cystic fibrosis: Report from the U.S. CF foundation remote endpoints task force. 2024
Jordana E Hoppe, and
Jacquelyn Sjoberg, and
Gina Hong, and
Katie Poch, and
Edith T Zemanick, and
Stephanie Thee, and
Claire Edmondson, and
Dhiren Patel, and
Meghana Sathe, and
Drucy Borowitz, and
Melissa S Putman, and
Noah Lechtzin, and
Kristin A Riekert, and
Melissa Basile, and
Christopher H Goss, and
Mary Elizabeth Jarosz, and
Margaret Rosenfeld
Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora CO, USA. Electronic address: jordana.hoppe@childrenscolorado.org.
The COVID-19 pandemic necessitated a rapid shift in clinical research to perform virtual visits and remote endpoint assessments, providing a key opportunity to optimize the use of remote endpoints for clinical trials in cystic fibrosis. The use of remote endpoints could allow more diverse participation in clinical trials while minimizing participant burden but must be robustly evaluated to ensure adequate performance and feasibility. In response, the Cystic Fibrosis Foundation convened the Remote Endpoint Task Force (Supplemental Table 1), a multidisciplinary group of CF researchers with remote endpoint expertise and community members tasked to better understand the current and future use of remote endpoints for clinical research. Here, we describe the current use of remote endpoints in CF clinical research, address key unanswered questions regarding their use and feasibility, and discuss the next steps to determine clinical trial readiness.
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