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.
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.
Session information:
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
Speakers
Kevin McCarthy, RPFT
Director Scientific Affairs at Clario
Kevin has worked in the field of lung function testing for 50+ years, with 40 years as the Manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System. He has always been passionate about the quality of pulmonary function measurements and has moved this passion to the clinical trial world where data quality is critical and where these measurements help accurately answer the questions we are asking. Kevin’s research experience includes managing the pulmonary function quality control in two NIH-funded registries: patients with severe A1AT deficiency and LAM Registry and the Cleveland Clinic’s NETT study. He has published extensively on pulmonary function testing and is a current member of the ATS PFT Committee and ATS/ERS Task Force to update the standards for Lung Volume testing for which he participated in 2019 to update the standards for Spirometry.
Philip Lake, Ph.D.
Senior Director, Respiratory Solutions at Clario
Phil is a respiratory specialist at Clario who supports global clients. He has held various roles in drug development for 20 years, predominantly focused on respiratory trials. Prior to Clario, Phil worked on several anti-inflammatory agents, dual and triple combination therapy, monoclonal antibody studies, anti-infectives and some of the largest mechanistic studies looking at biomarkers within sputum and biopsy samples at SmithKline Beecham and GlaxoSmithKline. He has experience supporting CROs as a respiratory specialist and as the Head of Project Management. Recently, his focus has been specifically on rare respiratory diseases, including cystic fibrosis and idiopathic pulmonary fibrosis, covering a variety of drug mechanisms and medical devices. Phil was pivotal to some of the first centralized overread studies and is committed to driving improvements in lung function testing.
Benoit Cuyvers
Product Manager at 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.