Citation

Lunt H, Heenan H. Contemp. Clin. Trials Commun. 2019; 16: e100487.

Affiliation

Diabetes Outpatients, Canterbury District Health Board, Christchurch, New Zealand.

Copyright

(Copyright © 2019, Elsevier Publishing)

DOI

10.1016/j.conctc.2019.100487

PMID

31872156

PMCID

PMC6915752

Abstract

Internationally, the frequency of emergencies and disasters affecting the built environment is increasing. Clinical trials sites that experience an event that affects their clinical trials research infrastructure and site functionality, may find their ability to follow optimal clinical trials conduct is compromised. There is however minimal published information on how clinical trials sites should best undertake emergency planning and develop resilience. We provide a description (case study) from a site perspective of two unforeseen events, one major and one minor, and discuss 'lessons learnt'. International collation of post-event information about what worked and what did not, collected across a spectrum of disasters and emergencies affecting facilities undertaking clinical trials, would provide a repository of shared knowledge and help inform the development of strategies aimed at enhancing the resilience of clinical trials sites to extreme events.

© 2019 The Author(s).

Language: en

Keywords

CRO, clinical research organisation; CTA, clinical trials agreement; Clinical research; Clinical trials; Disaster risk reduction; Emergency planning; IP, investigational product; SOPs, standard operating procedures