Impact of COVID-19 on Cystic Fibrosis Clinical Trials

In this webinar, Dr Damian Downey gives an overview on the impact of COVID-19 on Cystic Fibrosis clinical trials. This includes the ramifications of the pandemic on trial sponsors, participants, regulatory requirements, changing practice and research sites. He explores the challenge of patients being drafted from Cystic Fibrosis studies into those associated with COVID-19 and poses the question about how to maintain integrity for those pre-pandemic, ongoing, trials.

Additionally, Dr Downey presents a summary of ECFS-CTN survey results on the impact of SARS-CoV2 on clinical research.

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• Dr Damian Downey

  Consultant Respiratory Physician

  Read biography
  Dr Damian Downey

  Consultant Respiratory Physician Queen’s University Belfast & N. Ireland Regional Adult CF Centre

  Role and Location 

  Dr Downey is a consultant respiratory physician specialising in CF and bronchiectasis at Queen’s University Belfast and the N. Ireland Regional Adult CF Centre in Belfast. He is the current Director of the N. Ireland Regional Adult CF Centre.

  Education 

  He qualified in medicine from QUB and his early clinical training and airways inflammation research took place in Belfast. He subsequently trained in respiratory medicine in Manchester and Brisbane. In 2006 he was appointed as a consultant in CF and Respiratory medicine in Bristol and a honorary Clinical Senior Lecturer in the Department of Cellular and Molecular Medicine at the University of Bristol. In 2008 he became the Centre Director of the Bristol Adult CF centre and Director of the Adult Cystic Fibrosis Regional (Severn) Network. He returned to Belfast in 2011.

  Research Interests

  His research interests range from basic infection and inflammation in CF to clinical trials. His research focus is to optimise clinical response to established and new therapies. He leads investigator-initiated and pharmaceutical-sponsored research programs to support his research. His investigator led projects currently involve: Multi-modal analysis of pulmonary exacerbations in CF, exploring the potential for clinical and inflammatory biomarkers to predict response to treatment; The investigation and clinical application of novel biomarkers in CF; The bacterial impact of non-antimicrobial therapies in CF and repurposing drugs; The impact of co-morbidities in CF by deep patient phenotyping and utilising pre-clinical models to assess the mechanisms involved; Exploration of Patient Reported Outcome Measures for clinical trials; Interplay of bacteria and fungi in CF.

  Memberships

  He is director of the European CF Society – Clinical Trial Network (CTN). He also leads the CF pharmaceutical-sponsored clinical trial program in Belfast and links closely with the Northern Ireland Clinical Research Network (NICRN)-Respiratory Health and the Wellcome-Wolfson Clinical Research Facility. Their clinical research centre is also a member of the UK CF Trust Clinical Trials Accelerator Platform (CTAP) and he currently serves as a member of the Research Scientific Oversight Board for the CF Trust. He is a current member of the European CF Society Scientific Committee and a member of the UK CF Medical Association.