CLINICAL TRIALS OF ANTIFUNGAL THERAPIES

该合同的目标是提供一项临床试验 协作组访问适当的高危人群，并 提供构建和实施受控临床的专业知识 试验解决了严重真菌疾病的关键管理问题。 该小组将由一个协调机构进行协调和评估。 预计该小组将： 1)根据公共卫生制定优先考虑的科学议程 需要得到NIAID的批准； 2)确保为患者护理和相关成本提供行业支持，以实现 拟议的审判将一直持续到结束； 3)提供行政数据管理和统计支持 试验的制定、实施和分析； 4)提供现场监测、数据和安全质量保证；以及 5)评估和报告进展和结果，包括摘要和 根据独立数据和安全监测委员会的要求进行分析 为了所有研究的安全。

The objective of this contract is to provide a clinical trial collaborative group accessing the appropriate at-risk populations and providing the expertise to construct and conduct controlled clinical trials addressed the key management problems in serious fungal diseases. The group will be coordinated and evaluated by a coordinating institution. It is expected that the group will: 1) Formulates scientific agenda prioritized according to public health needs for approval by the NIAID; 2) Secure industrial support for patient care and related costs to enable the proposed trials to run to completion; 3) Provide administrative data management and statistical support for development, implementation and analysis of the trials; 4) Provide site monitoring and data and safety quality assurance; and 5) Assess and report progress and results, including summaries and analyses as required by an independent Data and Safety Monitoring Board and for the safety of all studies.