Balancing Clinical Reality vs Drug Development Needs – Enrolling the Right Patients
Fireside Chat: Designing the ‘Right’ PPF Trial – A Clinician & Developer Dialogue
- Identifying likely progressors by integrating clinical features, pulmonary function trends, imaging patterns, and recognizing the limitations of current PPF definitions
- Examining the current operational and scientific tension by exploring conflicts between ideal trial protocols and real-world patient heterogeneity, including practical recruitment, adherence, and site capability
- Balancing trial design with real-world practice, exploring conflicts, compromises, and the tension between idealized protocols and patient heterogeneity, including the artifact of a 52 week trial duration
- Collaborative perspective integrating clinician judgement, standardized imaging, and enrichment strategies to improve trial success as well as ability to generalize trial data to real-world patients
Designing the ‘Right’ PPF Trial: Clinical Reality vs Drug Development Needs