Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Silke van Koningsbruggen-Rietschel; Fiona Dunlevy; Veerle Bulteel; Kate Hayes; Anne Verbrugge; Hettie M. Janssens; Nadine Dufeu; Nicholas J. Simmonds; Lieven J. Dupont; Damian G. Downey

doi:10.1186/s13063-021-05457-5

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Silke van Koningsbruggen-Rietschel^*
, Fiona Dunlevy
, Veerle Bulteel
, Kate Hayes
, Anne Verbrugge
, Hettie M. Janssens
, Nadine Dufeu
, Nicholas J. Simmonds
, Lieven J. Dupont
, Damian G. Downey

^*Corresponding author for this work

Pediatrics

University Hospital Cologne
European Cystic Fibrosis Society
Queen's University Belfast
Aix-Marseille Université
Royal Brompton Hospital
University Hospitals Leuven

Research output: Contribution to journal › Article › Academic › peer-review

6 Citations (Scopus)

106 Downloads (Pure)

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.

Original language	English
Article number	578
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05457-5
Publication status	Published - 29 Aug 2021

Bibliographical note

Funding Information:
We acknowledge the input of clinical research teams at our 58 member sites, represented by their lead investigators: Michel Ab?ly, Celeste Barreto, Elisabetta Bignamini, Stephanie Bui, Mary Carroll, Carlo Castellani, Raphael Chiron, Marco Cipolli, Malena Cohen, Carla Colombo, Jane Davies, Damian Downey, Lieven Dupont, Elke De Wachter, Pavel Drevinek, Jamie Duckers, Helmut Ellemunter, Isabelle Fajac, Silvia Gartner, Marita Gilljam, Adrien Hal?sz, Charlie Haworth, Lena Hjelte, Lukas Homola, Alex Horsley, Hettie Janssens, Christiane Knoop, Tim Lee, Michael Lorenz, Vincenzia Lucidi, Gordon MacGregor, Marcus Mall, Christophe Marguet, Noel McElvaney, Ed McKone, Alexander Moeller, Susanne N?hrig, Paolo Palange, Isabelle Pin, Dario Prais, Tania Pressler, Anne Prevotat, Sophie Ramel, Philippe Reix, Gernot Rohde, Gary Ruiz, Dorota Sands, Florian Singer, Alan Smyth, Olaf Sommerburg, Sivagurunathan Sutharsan, Giovanni Taccetti, Suzanne Terheggen-Lagro, Burkhard T?mmler, Eva Van Braeckel, Kors van der Ent, Silke van Koningsbruggen-Rietschel, and Joanna Whitehouse. We would like to thank Isabelle Fajac, president of ECFS, for supporting this project.

Publisher Copyright:
© 2021, The Author(s).

Research programs

EMC OR-01-54-02

Access to Document

10.1186/s13063-021-05457-5Licence: CC BY

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemicFinal published version, 492 KBLicence: CC BY

Cite this

@article{985a7d185caa4dd383d77750646fc6d6,

title = "Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures",

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.",

author = "\{van Koningsbruggen-Rietschel\}, Silke and Fiona Dunlevy and Veerle Bulteel and Kate Hayes and Anne Verbrugge and Janssens, \{Hettie M.\} and Nadine Dufeu and Simmonds, \{Nicholas J.\} and Dupont, \{Lieven J.\} and Downey, \{Damian G.\}",

note = "Funding Information: We acknowledge the input of clinical research teams at our 58 member sites, represented by their lead investigators: Michel Ab?ly, Celeste Barreto, Elisabetta Bignamini, Stephanie Bui, Mary Carroll, Carlo Castellani, Raphael Chiron, Marco Cipolli, Malena Cohen, Carla Colombo, Jane Davies, Damian Downey, Lieven Dupont, Elke De Wachter, Pavel Drevinek, Jamie Duckers, Helmut Ellemunter, Isabelle Fajac, Silvia Gartner, Marita Gilljam, Adrien Hal?sz, Charlie Haworth, Lena Hjelte, Lukas Homola, Alex Horsley, Hettie Janssens, Christiane Knoop, Tim Lee, Michael Lorenz, Vincenzia Lucidi, Gordon MacGregor, Marcus Mall, Christophe Marguet, Noel McElvaney, Ed McKone, Alexander Moeller, Susanne N?hrig, Paolo Palange, Isabelle Pin, Dario Prais, Tania Pressler, Anne Prevotat, Sophie Ramel, Philippe Reix, Gernot Rohde, Gary Ruiz, Dorota Sands, Florian Singer, Alan Smyth, Olaf Sommerburg, Sivagurunathan Sutharsan, Giovanni Taccetti, Suzanne Terheggen-Lagro, Burkhard T?mmler, Eva Van Braeckel, Kors van der Ent, Silke van Koningsbruggen-Rietschel, and Joanna Whitehouse. We would like to thank Isabelle Fajac, president of ECFS, for supporting this project. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = aug,

day = "29",

doi = "10.1186/s13063-021-05457-5",

language = "English",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

TY - JOUR

T1 - Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic

T2 - risks and mitigation measures

AU - van Koningsbruggen-Rietschel, Silke

AU - Dunlevy, Fiona

AU - Bulteel, Veerle

AU - Hayes, Kate

AU - Verbrugge, Anne

AU - Janssens, Hettie M.

AU - Dufeu, Nadine

AU - Simmonds, Nicholas J.

AU - Dupont, Lieven J.

AU - Downey, Damian G.

N1 - Funding Information: We acknowledge the input of clinical research teams at our 58 member sites, represented by their lead investigators: Michel Ab?ly, Celeste Barreto, Elisabetta Bignamini, Stephanie Bui, Mary Carroll, Carlo Castellani, Raphael Chiron, Marco Cipolli, Malena Cohen, Carla Colombo, Jane Davies, Damian Downey, Lieven Dupont, Elke De Wachter, Pavel Drevinek, Jamie Duckers, Helmut Ellemunter, Isabelle Fajac, Silvia Gartner, Marita Gilljam, Adrien Hal?sz, Charlie Haworth, Lena Hjelte, Lukas Homola, Alex Horsley, Hettie Janssens, Christiane Knoop, Tim Lee, Michael Lorenz, Vincenzia Lucidi, Gordon MacGregor, Marcus Mall, Christophe Marguet, Noel McElvaney, Ed McKone, Alexander Moeller, Susanne N?hrig, Paolo Palange, Isabelle Pin, Dario Prais, Tania Pressler, Anne Prevotat, Sophie Ramel, Philippe Reix, Gernot Rohde, Gary Ruiz, Dorota Sands, Florian Singer, Alan Smyth, Olaf Sommerburg, Sivagurunathan Sutharsan, Giovanni Taccetti, Suzanne Terheggen-Lagro, Burkhard T?mmler, Eva Van Braeckel, Kors van der Ent, Silke van Koningsbruggen-Rietschel, and Joanna Whitehouse. We would like to thank Isabelle Fajac, president of ECFS, for supporting this project. Publisher Copyright: © 2021, The Author(s).

PY - 2021/8/29

Y1 - 2021/8/29

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85113815755

U2 - 10.1186/s13063-021-05457-5

DO - 10.1186/s13063-021-05457-5

M3 - Article

C2 - 34454570

AN - SCOPUS:85113815755

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

IS - 1

M1 - 578

ER -

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Abstract

Bibliographical note

Research programs

Access to Document

Other files and links

Fingerprint

Cite this