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

Content Provider	Springer Nature : BioMed Central
Author	Lim, Wei Shen Meakin, Garry Brittain, Clare Bewick, Thomas Duley, Lelia
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. Trial registration EudraCT Number 2013-001051-12, ISRCTN72331452 . Registered on 6 March 2013.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-017-2290-z.pdf
Ending Page	7
Page Count	7
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-017-2290-z
Journal	Trials
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2017-11-16
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Pandemic Influenza Clinical trial Simulation Hibernation Corticosteroids Delay Trial delivery Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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