CLINICAL TRIALS OF ANTIFUNGAL THERAPIES

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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.