All should be eligible? The great PAH trial debate

Presented at PVRI 2026 Congress by Sandeep Sahay, Houston Methodist Hospital, and Meredith Broderick, United Therapeutics 

Summary

Clinical trials for PAH face significant challenges, particularly due to designs that do not represent real-world patient demographics. Many patients are excluded based on strict criteria, which affects the relevance of trial results. There is a call for more inclusive designs that consider older patients with comorbidities, alongside critiques of the regulatory framework. Strategies from oncology are suggested to enhance trial enrolment and outcomes, emphasising the need for ethical enrichment strategies.

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