Navigating Respiratory Clinical Trials:
Ensuring Endpoint Integrity with Spirometry, HRCT and Patient-Centered Outcomes
Earn a Certificate of Live Attendance
AI Webinar Explorer available after event
About this webinar
In the rapidly evolving landscape of respiratory clinical development, aligning cutting-edge strategies with robust trial design is crucial. Respiratory clinical trials require reliable endpoints that capture treatment effects while keeping patients at the center.
This webinar will examine key considerations for optimizing respiratory clinical trials, focusing on the essential role of spirometry, high-resolution computed tomography (HRCT) and patient-centered outcomes.
The session will provide practical insights into integrating spirometry, HRCT and patient-centered outcomes within respiratory trials. It will explore the importance of these endpoints across various indications and discuss strategies to reduce variability and maintain consistency throughout the trial process.
The expert panel will provide a comprehensive overview of:
- Spirometry: Fundamental applications in clinical trials, measurement techniques, validation, training and patient support strategies to optimize data accuracy and reliability
- HRCT: The value of historical scans, establishing quantitative endpoints and the advantages of central over-read processes to enhance data quality and consistency
- Patient-Centered Outcomes: The importance of patient-reported outcomes (PROs), quality-of-life assessments, the role of ePROs and strategies to support site and patient compliance
Register for this webinar to learn how integrated endpoint strategies can improve data reliability, reduce variability and support informed decision-making in respiratory clinical trials.
Who should attend
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What you will learn
- Spirometry
- High-resolution computed tomography (HRCT)
- Patient-centered outcomes
Featured Speakers
Puneet Agarwal, MD
Dr. Puneet Agarwal is a certified Pulmonologist with over 4 years of industry experience and over 10 years of clinical experience. He has extensive experience in respiratory trials, including asthma, COPD, IPF, ILD, AATD, pulmonary hypertension and more. Dr. Agarwal has previous experience as a Principal Investigator on industry-sponsored clinical trials.
Carrie Sheil
Carrie Sheil brings more than 23 years of clinical research and industry experience. She provides strategic operational leadership for global, Phase I-IV trials across respiratory and other complex therapeutic areas, including infectious diseases and vaccines, women’s health, immunology, inflammation and rare diseases. Her experience spans a broad range of indications, with an emphasis on navigating complex operational and endpoint considerations across global development programs. She has successfully led multidisciplinary teams supporting development programs that have resulted in both FDA and EMA approvals.
Cinzia Giansante
Cinzia Giansante has over 18 years of international clinical research experience. She has managed international Phase Ib-IV studies in multiple therapeutic areas, including respiratory (IPF, pulmonary sarcoidosis and asthma), rheumatology, rare diseases, immunology and oncology. She has extensive experience executing global studies from start-up through close-out.
Max Hammond, PhD
Dr. Max Hammond has a PhD in Biomedical Engineering focused on imaging quantitation with over 20 peer-reviewed publications. He has over 15 years of experience designing, conducting and managing studies using CT/HRCT, DXA, MRI, U/S, ECHO, ECG, microscopy, spectroscopy and imaging-based computer modeling. He has direct global project management experience for Phase I-III clinical trials in pediatric and adult populations across a variety of indications, including respiratory.
Partner for this event
Medpace
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.