Universität zu Köln

Van Koningsbruggen-Rietschel, Silke, Dunlevy, Fiona, Bulteel, Veerle, Hayes, Kate ORCID: 0000-0001-5561-8893, Verbrugge, Anne, Janssens, Hettie M., Dufeu, Nadine, Simmonds, Nicholas J., Dupont, Lieven J. and Downey, Damian G. (2021). Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures. Trials, 22 (1). LONDON: BMC. ISSN 1745-6215

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Abstract

The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites across 17 European countries and collated information on measures to mitigate the impact of the pandemic and ensure trial continuity. Here, we present recommendations on how to reduce the risk of SARS-CoV-2 exposure to patients and trial staff by implementing remote trial visits where possible, using home assessments, video and phone calls, electronic consent, and home delivery of study drugs. We discuss the practicalities of remote source data verification, protocol amendments, changing trial site location, and staff absences and home working. We outline recommendations on how to protect trial outcomes, including home assessments, safety reporting, protocol deviations, and recruitment challenges. Finally, we discuss the importance of continued access to study drugs via extension trials for some patients. This guidance was co-created from the shared knowledge and experience of sites in our network and was re-distributed directly to all ECFS-CTN sites to help mitigate the impact of further waves of the SARS-CoV-2 pandemic. We will also use this guidance to assist companies, academia, and consortia with future protocol design and risk mitigation plans. This guidance can be applied to clinical trials in other diseases and could help sites that are not supported by clinical trial networks.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Van Koningsbruggen-Rietschel, Silke UNSPECIFIED UNSPECIFIED UNSPECIFIED Dunlevy, Fiona UNSPECIFIED UNSPECIFIED UNSPECIFIED Bulteel, Veerle UNSPECIFIED UNSPECIFIED UNSPECIFIED Hayes, Kate UNSPECIFIED orcid.org/0000-0001-5561-8893 UNSPECIFIED Verbrugge, Anne UNSPECIFIED UNSPECIFIED UNSPECIFIED Janssens, Hettie M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dufeu, Nadine UNSPECIFIED UNSPECIFIED UNSPECIFIED Simmonds, Nicholas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dupont, Lieven J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Downey, Damian G. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-597102
DOI:	10.1186/s13063-021-05457-5
Journal or Publication Title:	Trials
Volume:	22
Number:	1
Date:	2021
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59710