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. 2021 Apr 14;22(1):278.
doi: 10.1186/s13063-021-05200-0.

Conducting clinical trials during the COVID-19 pandemic-a collaborative trial network response

Laura Robison  1 , Yeoungjee Cho  2   3 , Andrea K Viecelli  2   3 , David W Johnson  2   3   4 , Carmel M Hawley  2   3   4 , Andrea Valks  2 , Peta-Anne Paul-Brent  2 , Ruth Stastny  2 , Julie Varghese  2 , Charani Kiriwandeniya  2 , Elaine M Pascoe  2 , Liza A Vergara  2 , Magid A Fahim  2   3   5 , Neil Boudville  2   6 , Rathika Krishnasamy  2   7 , Donna Reidlinger  2 ; Australasian Kidney Trials Network
Affiliations

Conducting clinical trials during the COVID-19 pandemic-a collaborative trial network response

Laura Robison et al. Trials. .

Abstract

The unprecedented demand placed on healthcare systems from the COVID-19 pandemic has forced a reassessment of clinical trial conduct and feasibility. Consequently, the Australasian Kidney Trials Network (AKTN), an established collaborative research group known for conducting investigator-initiated global clinical trials, had to efficiently respond and adapt to the changing landscape during COVID-19. Key priorities included ensuring patient and staff safety, trial integrity and network sustainability for the kidney care community. New resources have been developed to enable a structured review and contingency plan of trial activities during the pandemic and beyond.

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Conflict of interest statement

All authors have completed the Unified Competing Interest form (available on request from the corresponding author). YC has received research grants and speaker’s honoraria from Baxter Healthcare, Fresenius medical care and Amgen. She is a current recipient of the NHMRC Early Career Fellowship. AVi is a current recipient of a Jacquot Research Establishment Fellowship. DJ has received consultancy fees, research grants, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care; consultancy fees from Astra Zeneca and AWAK; speaker’s honoraria and travel sponsorships from ONO; and travel sponsorships from Amgen. He is a current recipient of an Australian National Health and Medical Research Council Practitioner Fellowship. CH has received grants from National Health and Medical Research Council, Shire and Baxter, and consultancy fees from GlaxoSmithKline and Astra Zeneca paid to her institution and outside the submitted work. MF has received research grants from Baxter Healthcare, Siemens Healthcare and Roche Diagnostics. NB has received an educational grant, advisory board consulting fees and honoraria from Baxter; advisory board consulting fees from Astra Zeneca; an educational grant and travel grant from Roche Pharmaceuticals; and a travel grant and educational grant from Amgen. RK has received consultancy fees, research grants, travel and speaker’s honoraria from Baxter Healthcare, travel sponsorships from Amgen and speaker’s honoraria from Shire. She is a current recipient of Queensland Advancing Clinical Research Fellowship. Staff members of AKTN are supported by NHMRC funding. The remaining authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
AKTN governance structure
Fig. 2
Fig. 2
Summary of trial response process
Fig. 3
Fig. 3
a Pragmatic changes to the delivery of trial monitoring activities during COVID-19 restrictions. b Pragmatic changes to the delivery of trial activities during COVID-19 restrictions
Fig. 4
Fig. 4
Considerations for the design of future trials
See this image and copyright information in PMC

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