Going Beyond ATS/ERS 2019 Guidelines for Your Respiratory Clinical Trials

Join this insightful webinar in which the expert speakers will explore the evolution of data quality assessments in respiratory drug development. Historically, adherence to enforced spirometry standards from the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines has been the acceptable measure of high-quality data. However, despite refinements made in 2019 to address limitations in the historical standards, inconsistencies and aberrant treatment effects remain a persistent challenge, raising concerns over data accuracy.

Clario, a leader in clinical research technology, has been initiating a more focused approach to ensure respiratory data accuracy within clinical trials. By introducing data plausibility as an additional quality step, data anomalies can be identified early on, thus mitigating risks and accelerating drug development timelines.

In this webinar, the speakers will explore the following topics:

• Limitations of traditional adherence to ATS/ERS enforced spirometry standards
• Role of data plausibility in enhancing data accuracy and reliability
• Impact of data plausibility on identifying inconsistencies and aberrant treatment effects
• Potential of embedding data plausibility within AI functionality to drive high-quality data
• How improved data quality can accelerate drug development, reduce costs and enable better development decisions for personalized medicine

Register for this webinar today to gain valuable insights into the future of data quality assessment in respiratory drug development and learn how you can leverage these advancements to drive success in your respiratory clinical trials.

Speakers

Kevin McCarthy, RPFT, Director, Scientific Affairs, Clario

Kevin McCarthy has worked in the field of lung function testing for 50+ years, with nearly 40 years as the Manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System. Kevin’s research experience includes managing the pulmonary function quality control in two NIH-funded registries. He has published extensively on pulmonary function testing and is a past member of the ATS PFT Committee and served on the ATS/ERS Task Forces to update the Spirometry and Lung Volume standards.

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Philip Lake, PhD, Senior Director, Respiratory Solutions, Clario

Philip Lake is a respiratory specialist at Clario. He has held various roles in drug development for 20 years, predominantly focused on respiratory drug development. He has led the respiratory strategy for a number of CROs and held positions as Head of European Project Management for two of these companies. In addition to classic regulatory indications his recent focus has been on the use of lung function endpoints as a biomarker in rare disease and neurodegenerative disorders. Phil was pivotal to some of the first centralized overread studies and is committed to driving improvements in lung function testing through a better understanding of data plausibility and variability to generate new data.

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Benoit Cuyvers, Product Manager, ArtiQ

Benoit Cuyvers is the product manager of the Clinical Research Portfolio of ArtiQ (Leuven, Belgium), a company that aims to empower respiratory research & medicine with artificial intelligence. He has been leading the efforts on ArtiQ’s AI-enabled Risk Based Monitoring system (ArtiQ.RBM), from concept to solution. With his background in Bioscience Engineering and his past experience as a digital health expert at Siemens, Benoit is able to apply learnings from other medical and technical fields to the field of AI in respiratory research & medicine.

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