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. 2021 Mar;20(2):195-197.
doi: 10.1016/j.jcf.2020.12.007. Epub 2020 Dec 15.

The impact of SARS-CoV-2 on the cystic fibrosis foundation therapeutics development network

Kelsie Pearson  1 , Nicole Mayer-Hamblett  2 , Christopher H Goss  3 , George Z Retsch-Bogart  4 , Jill M VanDalfsen  5 , Patricia Burks  6 , Daniel Rosenbluth  7 , John Paul Clancy  6 , Amy Hoffman  5 , David P Nichols  8
Affiliations

The impact of SARS-CoV-2 on the cystic fibrosis foundation therapeutics development network

Kelsie Pearson et al. J Cyst Fibros. 2021 Mar.

Abstract

The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) global pandemic significantly impacted CF clinical research within the Cystic Fibrosis Foundation Therapeutics Development Network (CFF TDN). A Research Electronic Data Capture (REDCap) survey was developed and sent to network sites to monitor and understand the impact on research teams, ongoing and anticipated clinical research, and specific clinical and research procedures. Key findings indicated an early impact on participant enrollment, research team stability, and procedures such as spirometry and sputum induction. These trends steadily improved over the months as research activities began to recover across the TDN. While SARS-CoV-2 created a significant challenge it also highlights new opportunities to expand CF research with greater focus on data collection outside of research centers and increased access for remote participation.

Keywords: Clinical research; Coronavirus; Cystic fibrosis; SARS-CoV-2.

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Conflict of interest statement

Declaration of Competing Interest NMH has received grant funding from the Cystic Fibrosis Foundation (CFF) and National Institutes of Health (NIH). CHG reports grant funding from CFF, European Commission, National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Research Resources, Gilead Sciences, Novartis, NIH, Food and Drug Administration, Boehringer Ingelheim, Vertex Pharmaceuticals. None of the work presented in this short communication was influenced by the funding sources reported by CHG. KP, GZRB, JMVD, PB, DR., JPC, AH, and DPN have nothing to disclose related to this work.

Figures

Fig 1
Fig. 1
SARS-CoV-2 Impact on CF Therapeutic Development Network. Left: Significant impact on participant enrollment reported in the initial months with steady improvement seen through September. Center: Operational response to SARS-CoV-2 to minimize risk of missing participant data and reduced safety monitoring. Right: Ability of sites to perform spirometry and sputum collection either in clinic or at home. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)
See this image and copyright information in PMC

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