Advancing Real-World Evidence in Obstructive Hypertrophic Cardiomyopathy

Building a Global Framework for RWE

To strengthen understanding of how therapies perform in everyday clinical settings, BMS has developed a global RWE framework connecting data from diverse healthcare systems and patient populations.

The company’s WAYFARER-HCM initiative, which includes the COLLIGO-HCM study, spans seven countries and more than 4,000 patients.

“The WAYFARER-HCM program is an umbrella name for a number of real-world datasets,” Grasela said. “In the WAYFARER program, we’ve assessed community and hospital settings, patient outcomes, as well as physician assessments.”

Within this framework, studies draw on sources such as medical and pharmacy insurance claims and anonymized clinical records to evaluate outcomes, treatment patterns and safety metrics across different care environments.

“Using real-world data and bringing it down to the actual clinical practitioner and their day-to-day care of patients provides an opportunity to enhance the number of patients and the data that can be pooled together,” he said.

This integrated approach not only enhances statistical robustness but also helps ensure that efficacy and safety findings reflect the diversity of real-world care globally.

Real-World Data Through a Global Lens

One of the defining strengths of RWE programs, according to Dr. Grasela, is their ability to capture diversity, both in demographics and healthcare settings.

“When you conduct a clinical trial, we at BMS always strive for diversity in our programs, but that’s not always possible; we can’t go to every country and every site,” he explained. “In real-world datasets, we can observe patients from different regions, ethnicities and healthcare systems, all managed under their local standards of care. That diversity makes the evidence stronger.”

This inclusivity is especially relevant in oHCM, where genetic variability and environmental factors can influence how the disease presents and progresses. By examining outcomes across such varied populations, researchers can better understand how targeted cardiovascular therapies perform outside of controlled clinical trial conditions.

With clinical trial outcomes and real-world findings, programs like WAYFARER-HCM are helping reshape cardiovascular research into a more inclusive, data-driven and globally representative model of care.