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- Title
Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned.
- Authors
Reynolds, Penny S.; Michael, Mary J.; Spiess, Bruce D.
- Abstract
<bold>Background: </bold>Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the 'gold standard' management system developed for managing diverse operations in major incident and public health arenas. It enables effective and flexible management through integration of personnel, procedures, resources, and communications within a common hierarchical organisational structure. Conventional ICS organisation consists of five function modules: Command, Planning, Operations, Logistics, and Finance/Administration. Large clinical trials will require a separate Regulatory Administrative arm, and an Information arm, consisting of dedicated data management and information technology staff. We applied ICS principles to organisation and management of the Prehospital Use of Plasma in Traumatic Haemorrhage (PUPTH) trial. This trial was a multidepartmental, multiagency, randomised clinical trial investigating prehospital administration of thawed plasma on mortality and coagulation response in severely injured trauma patients. We describe the ICS system as it would apply to large clinical trials in general, and the benefits, barriers, and lessons learned in utilising ICS principles to reorganise and coordinate the PUPTH trial.<bold>Results: </bold>Without a formal trial management structure, early stages of the trial were characterised by inertia and organisational confusion. Implementing ICS improved organisation, coordination, and communication between multiple agencies and service groups, and greatly streamlined regulatory compliance administration. However, unfamiliarity of clinicians with ICS culture, conflicting resource allocation priorities, and communication bottlenecks were significant barriers.<bold>Conclusions: </bold>ICS is a flexible and powerful organisational tool for managing large complex clinical trials. However, for successful implementation the cultural, psychological, and social environment of trial participants must be accounted for, and personnel need to be educated in the basics of ICS.<bold>Trial Registration: </bold>ClinicalTrials.gov, NCT02303964 . Registered on 28 November 2014.
- Subjects
CLINICAL trials; INCIDENT command systems; PUBLIC health; DATA management; SOCIAL context; HEMORRHAGE diagnosis; HEMORRHAGE treatment; TRAUMATOLOGY diagnosis; WOUND care; EDUCATION of research personnel; BLOOD coagulation; BLOOD plasma; COMPARATIVE studies; EMERGENCY medical services; EMPLOYEE orientation; RED blood cell transfusion; EXPERIMENTAL design; HEALTH care teams; HEMORRHAGE; INTEGRATED health care delivery; MANAGEMENT; RESEARCH methodology; MEDICAL cooperation; MEDICAL protocols; RESEARCH; SYSTEM analysis; WOUNDS &; injuries; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; RESEARCH personnel
- Publication
Trials, 2017, Vol 18, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1755-9