Kagan Jonathan M, Kane Mary, Quinlan Kathleen M, Rosas Scott, Trochim William M K
Division of Clinical Research, NIAID/NIH, Bethesda, Maryland, USA.
Health Res Policy Syst. 2009 May 21;7:12. doi: 10.1186/1478-4505-7-12.
Globally, health research organizations are called upon to re-examine their policies and practices to more efficiently and effectively address current scientific and social needs, as well as increasing public demands for accountability.Through a case study approach, the authors examine an effort undertaken by the National Institute of Allergy & Infectious Diseases (part of the National Institutes of Health, Department of Health & Human Services, United States Government) to develop an evaluation system for its recently restructured HIV/AIDS clinical trials program. The challenges in designing, operationalizing, and managing global clinical trials programs are considered in the context of large scale scientific research initiatives.Through a process of extensive stakeholder input, a framework of success factors was developed that enables both a prospective view of the elements that must be addressed in an evaluation of this research and a current state assessment of the extent to which the goals of the restructuring are understood by stakeholders across the DAIDS clinical research networks.
在全球范围内，卫生研究组织被要求重新审视其政策和做法，以便更高效、有效地满足当前的科学和社会需求，以及公众对问责制日益增长的要求。通过案例研究方法，作者考察了美国国立过敏与传染病研究所（隶属于美国卫生与公众服务部国立卫生研究院）为其最近重组的艾滋病毒/艾滋病临床试验项目开发评估系统所做的努力。在大规模科学研究倡议的背景下，考虑了设计、实施和管理全球临床试验项目所面临的挑战。通过广泛的利益相关者参与过程，制定了一个成功因素框架，该框架既能前瞻性地审视评估该研究时必须考虑的要素，又能对艾滋病临床试验网络中各利益相关者对重组目标的理解程度进行现状评估。
