Naydeck B L, Sutton-Tyrrell K, Burek K, Sopko G S
BARI Clinical Coordinating Center, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, PA 15261, USA.
Control Clin Trials. 1996 Jun;17(3):226-34. doi: 10.1016/0197-2456(95)00136-0.
Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques. While the scientific community typically views a clinical trial as one large and cohesive enterprise, at each site the trial may actually be conducted as a small project related to the medical specialty of the investigator. Therefore overall trial management must be accomplished through collaboration rather than through direct management. In the Bypass Angioplasty Revascularization Investigation (BARI), the BARI clinical coordinating center has designed and utilized several mechanisms that facilitate effective communication and administrative control of a multicenter clinical trial. These mechanisms provide a framework of communication techniques that accommodate the specific needs of a complex organization.
对于多中心随机临床试验的众多运营组成部分而言，高效沟通是一项挑战。传统管理理论认为，沟通通常沿着等级组织结构所确立的路径进行。多中心临床试验不太适合传统的组织模式，需要对传统沟通技巧加以改进。虽然科学界通常将临床试验视为一个庞大且紧密的事业，但在每个试验点，该试验实际上可能作为一个与研究者医学专业相关的小项目来开展。因此，整体试验管理必须通过协作而非直接管理来实现。在“搭桥血管成形术血运重建研究”（BARI）中，BARI临床协调中心设计并运用了多种机制，以促进多中心临床试验的有效沟通和行政管理。这些机制提供了一个沟通技巧框架，可适应复杂组织的特定需求。
