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Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial

Lim, Wei Shen; Meakin, Garry; Brittain, Clare; Bewick, Thomas; Duley, Lelia

Authors

Wei Shen Lim weishen.lim@nuh.nhs.uk

Thomas Bewick

Lelia Duley lelia.duley@nottingham.ac.uk



Abstract

Background: Research in public health emergencies requires trials to be set up in readiness for activation at short notice and in anticipation of limited timelines for patient recruitment. We conducted a simulated activation of a hibernating pandemic influenza clinical trial in order to test trial processes and to determine the value of such simulation in maintaining trial readiness.
Methods: The simulation involved the Nottingham Clinical Trials Unit, one participating hospital, one manufacturing unit and the Investigational Medicinal Product (IMP) supplier. During the exercise, from 15 September 2015 to 2 December 2015, clinical staff at the participating site completed the trial training package, a volunteer acting as a patient was recruited to the study, ‘dummy’ IMP was prescribed and follow-up completed.
Results: Successful activation of the hibernating trial with patient recruitment within 4 weeks of ‘arousal’ as planned was demonstrated. A need for greater resilience in anticipation of staff absenteeism was identified, particularly in relation to key trial procedures where the potential for delay is high. A specific issue relating to the IMP Stock Control System was highlighted as a potential source of error that could compromise the randomisation sequence. The simulation exercise was well received by site investigators and increased their confidence in being able to meet the likely demands of the trial when activated. The estimated cost of the exercise was £1995; 90% of this being staff costs.
Conclusions: Simulated activation is useful as a means to test, and prepare for, the rapid activation of ‘hibernating’ research studies. Whether simulation exercises can also help reduce waste in complex clinical trial research deserves further exploration.

Journal Article Type Article
Publication Date Nov 16, 2017
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Not Peer Reviewed
Volume 18
Article Number 546
Pages 1-7
APA6 Citation Lim, W. S., Meakin, G., Brittain, C., Bewick, T., & Duley, L. (2017). Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial. Trials, 18, 1-7. https://doi.org/10.1186/s13063-017-2290-z
DOI https://doi.org/10.1186/s13063-017-2290-z
Keywords Pandemic, Influenza, Clinical trial, Simulation, Hibernation, Corticosteroids, Delay, Trial delivery
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2290-z
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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