Selection Criteria and Prioritization of Resuscitation Fluid Adjuvants

摘要

To provide the sponsor with advice on criteria useful for evaluating potential technologies/products for resuscitation fluid for use by first- responders in combat. LSRO was also tasked with prioritizing pre-proposals and full proposals most warranting an investment in Sponsor resources. SCOPE The Phase I review of pre-proposals included those received in response to a public call for information on the topic of resuscitation fluids or components of fluids or adjuvant therapies and excluded equipment such as infusion and monitoring devices. Reviews were to include consideration of the military relevance of the product, the stage of product development, and the scientific merits of the investigation. In Phase 2, processes and forms currently in use by the military and other federal programs for the review of scientific research were examined with an eye towards improvements that would yield the type of data and information necessary for future expert reviews. The Phase 3 review of full proposals was limited to 12 received in response to 16 invitations (i.e., the highest ranking pre-proposals). MAJOR FINDINGS Phases I and 2: Of the 10 clinical pre-proposals reviewed, the expert panel identified 2 leading candidates. Of the 49 preclinical pre-proposals reviewed, the expert panel identified 5 top-tier pre-proposals and 9 second-tier pre-proposals. Phase 3: The review of 12 full proposals yielded 5 high ranking experimental products, most of which are likely to be ready for clinical testing by 2008. SIGNIFICANCE Development of one or more of the highest ranking novel strategies to treat hemorrhagic shock may improve effectiveness of resuscitation fluids, reducing the number of military casualties who are killed-in-action. Furthermore, the LSRO expert panel developed new proposal forms, that improved the quality, relevance, and organization of information provided for review of proposals beyond that provided by earlier instructions.