Speaker
Dr. Todd Lustine, Kevin McCarthy, Amit Vasanji, Dr. Peter Cho
When and where
Starts: Tuesday, 22 April 2025 - 11:00
Ends: Tuesday, 22 April 2025 - 12:00
Location:
Xtalks, Toronto, Canada
Location details: Free Registration on Xtalks.com
Event description
Interstitial lung disease (ILD) represents a diverse group of disorders characterized by infiltration of lung parenchyma with extracellular matrix, leading to progressive respiratory impairment and respiratory failure over time.
Patients often experience debilitating symptoms such as breathlessness and chronic cough, significantly affecting their quality of life and limiting daily activities. Treatment options for ILD are limited and vary based on disease etiology and progression. While antifibrotic agents such as nintedanib and pirfenidone have shown efficacy in slowing disease progression, there remains a significant unmet need with novel therapies directed at both underlying pathophysiology and symptomatic relief under active clinical development.
The application of meaningful and measurable endpoints is essential for the success of ILD clinical trials. However, regulatory challenges persist, particularly in validating novel digital biomarkers and patient-reported outcomes (PROs). Regulatory agencies emphasize the need for standardized, reproducible measures that demonstrate clinical relevance, necessitating rigorous validation studies and alignment with evolving guidelines for digital health technologies (DHTs) in clinical trials.
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Endpoint selection in ILD trials must incorporate a multi-faceted approach, combining physiologic, imaging and patient-centric measures. By leveraging respiratory function assessments, medical imaging technologies and digital health solutions, sponsors can enhance data quality, optimize patient-centric evaluations and accelerate therapeutic advancements while improving the trial-participant experience.
Cough is a frequently occurring symptom for patients with ILD; it can present as the earliest and only symptom, and besides dyspnea, is reported to be one of the most distressing. Capture of cough frequency and severity, which is often underrepresented in traditional assessments, has historically relied on patient and/or surrogate recall via patient-reported diaries.
Accuracy of assessment and clinical trial participant burden can be improved with advanced monitoring tools. Application of technologies, like the RESP® Biosensor, offers continuous, accurate and non-invasive assessment. Integrating such technologies enhances endpoint reliability and supports regulatory decision-making.
Advancing clinical development for ILD therapeutics requires thoughtful endpoint selection to ensure meaningful, patient-focused outcomes. The integration of the range of comprehensive endpoint solutions represents a proven approach to refining clinical trial methodologies. By prioritizing objective and patient-relevant measures, researchers can drive more effective and impactful treatment strategies for ILD patients worldwide while aligning with evolving regulatory expectations for digital health endpoints in clinical trials.
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Register for this webinar to learn about the latest advancements in ILD clinical trial design from endpoint selection and novel cough monitoring tech to patient-centric trial design and imaging solutions.
Further details
IMPORTANT: In order to register to this free webinar you must register directly on Xtalks via the following URL: https://xtalks.com/webinars/from-symptoms-to-solutions-enhancing-interstitial-lung-disease-ild-trials-with-next-gen-assessments/
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