Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned

Abstract

Background: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov, NCT02303964 . Registered on 28 November 2014.

Keywords: ICS; Incident Command Structure; Trial failure; Trial management.

Figures

Fig. 1

Conventional clinical trial management architecture (adapted from [9]). This is ‘flat land’ management [10], as the lead investigator is directly involved with all aspects of trial management. Although communication chains are short, the lead investigator can be easily overwhelmed by information and low-level decision-making

Fig. 2

Incident Command Structure as applied to clinical trial management. Advantages are more manageable span of control, more effective coordination of diverse tasks, and more effective allocation of tasks and functions to teams with specific expertise and oversight skills

Fig. 3

Generalised task flow maps for the PUPTH trial. Integration of Patient Flow with Information Flow maps was crucial for identifying barriers to data collection; blood samples (non-standard information) had to be collected at predesignated time points; however, patient location in the hospital care chain at those times could not be predicted in advance

Fig. 4

Incident Command Structure as applied to management of the PUPTH trial. This schematic clearly identified chains of command, responsible personnel, and task and service units. It made for more effective allocation and monitoring of tasks, simplified coordination and coverage of essential service personnel, and improved accountability