Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Am J Gastroenterol. 2012 May;107(5):644-9. doi: 10.1038/ajg.2011.475.
The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.
当前的医疗环境需要基于证据的医学，这依赖于临床试验作为决策的基础。临床研究人员越来越多地发现，他们个人负责协调大型多中心试验。我们提出了成功实施和管理多中心临床试验的策略，以及通过一项国际多中心随机临床试验获得的知识。主题包括团队组成、监管要求、研究组织和治理、沟通策略、招募和保留努力、预算、技术转让和发表。
