Lessons learned from the feasibility phase of the REvascularization CHoices Among Under-Represented Groups Evaluation (RECHARGE) trial program.
Mario Gaudino, Gregg W Stone, John Puskas et al.
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In 30 seconds
The RECHARGE trial program, a multicenter randomized controlled trial, aimed to enroll 1200 women, Black, and Hispanic patients to compare percutaneous coronary intervention and coronary artery bypass grafting. The pilot phase exceeded its enrollment goal, randomizing 141 patients within 13 months, highlighting challenges in patient recruitment and the need for tailored engagement strategies.
Key findings
- 141 patients were randomized within 13 months, exceeding the pilot goal of 60 participants.
- Median activation time for sites was 10.8 months, with an interquartile range of 9.1-13.6.
- Many eligible patients were not randomized due to physician and patient treatment preferences.
- 65 out of 91 selected sites were activated during the pilot phase.
Why it matters
Understanding the barriers to enrollment in clinical trials for under-represented populations is crucial for improving diversity in research. This can enhance the generalizability of findings and ensure that treatment options are effective across different demographic groups.