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

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development,
  • Wednesday, April 17, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

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, Clario

Kevin McCarthy, RPFT, Director, Scientific Affairs, Clario

Kevin McCarthy 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.

Message Presenter
Phil Lake, Clario

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

Philip Lake 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.

Message Presenter

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.

Message Presenter

Who Should Attend?

This webinar will appeal to the following professionals:

  • Clinical Pharmacologists​
  • Clinical operations (early phase)​
  • TA Experts for Respiratory​
  • Medical Monitor / Head of Development for Program​
  • Clinical operations
  • Clinical development
  • Clinical research​​
  • Regulatory affairs ​
  • Clinical monitoring​​
  • Clinical Scientists​​
  • Protocol Managers​​
  • Clinical Data Managers​​
  • Chief Medical Officer​

What You Will Learn

The attendees will learn the following:

  • Understand why the standards were drafted and adapted to the pharma industry and what the standards mean for the clinical research industry
  • Review what is being seen in clinical trials, including trends in training and data acquisition
  • Learn how inconsistent data detection, methodology and outcome reporting can be improved
  • Explore how standard overread ATS/ERS can be done with AI support

Xtalks Partner

Clario

Clario is a leading healthcare research and technology company that generates the highest quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world.

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