Reynolds Penny S, Michael Mary J, Spiess Bruce D
Department of Anesthesiology, Virginia Commonwealth University Medical Center, Richmond, VA, USA.
Present address: Department of Anesthesiology, University of Florida, Gainesville, FL, USA.
Trials. 2017 Feb 9;18(1):62. doi: 10.1186/s13063-016-1755-9.
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.
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.
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.
ClinicalTrials.gov, NCT02303964 . Registered on 28 November 2014.
临床试验的成功取决于恰当的管理，但目前缺乏针对试验组织与规划的实用指导。 incident指挥系统（ICS）是为管理重大事件和公共卫生领域的各类行动而开发的“黄金标准”管理系统。它通过在一个通用的层级组织结构内整合人员、程序、资源和通信，实现有效且灵活的管理。传统的ICS组织由五个功能模块组成：指挥、规划、行动、后勤以及财务/行政。大型临床试验将需要一个单独的监管行政部门以及一个信息部门，该信息部门由专门的数据管理和信息技术人员组成。我们将ICS原则应用于创伤性出血院前血浆使用（PUPTH）试验的组织与管理。这项试验是一项多部门、多机构的随机临床试验，旨在研究院前给予解冻血浆对严重创伤患者死亡率和凝血反应的影响。我们描述了ICS系统在一般大型临床试验中的应用方式，以及在利用ICS原则重组和协调PUPTH试验过程中的益处、障碍和经验教训。
在没有正式试验管理结构的情况下，试验早期阶段表现为惰性和组织混乱。实施ICS改善了多个机构和服务组之间的组织、协调与沟通，并极大地简化了监管合规管理。然而，临床医生对ICS文化不熟悉、资源分配优先级冲突以及沟通瓶颈是重大障碍。
ICS是管理大型复杂临床试验的灵活且强大的组织工具。然而，为了成功实施，必须考虑试验参与者的文化、心理和社会环境，并且需要对人员进行ICS基础知识培训。
ClinicalTrials.gov，NCT02303964。于2014年11月28日注册。
