Critical illness and injury are leading causes of death and disability world- wide. Despite our nation's expertise and the imperative to improve outcomes for the critically ill and injured, the US does not have a federally-funded critical care research network for adults. Instead, funding for critical illness and injury research is divided along organ-based or disease-based lines across federal agencies, including but not limited to institutes and offices within the NIH, CDC, and DOD, among others. Moreover, there is little interaction between many existing NIH large-scale critical illness and injury research programs. As a result, there has been a call for better communication, synergy, and funding efficiency at a national level, thereby improving the breadth and quality of acute care research. Indeed, the emergence of a systems-based approach for the study of critical illness and injury demands this sort of scientific and inter-agency interaction, as reflected by recent NIH trans-Institute program announcements. To address these needs, this grant will create a US Critical Illness and Injury Trials Group (USCIITG) meeting. The Group will facilitate collaboration among experts with the goal of promoting clinical trials in the critically ill or injured. This grant will not fund clinical trials per se, but rather promote at quarterly meetings the development of evidence-based clinical protocols and the subsequent preparation of applications for funding to test specific hypotheses.
The specific aims i nclude the following: 1) Establish an inclusive, nationwide network of experts to review published data, establish national priorities, vet hypotheses, write clinical protocols, and generate pilot data;2) Promote interaction and synergy across established programs, both academic and non-academic, to improve the robustness of clinical trails and test hypotheses in a US population;3) Provide a venue to educate and train clinicians of all backgrounds in the science of trial design, conduct, analysis, and reporting;4) Insure patient protection and privacy by addressing the ethical, legal, and social implications (ELSI) of research in the specialized circumstance of critical illness or injury. The USCIITG will be governed by steering and organizational committees. The USCIITG will convene yearly meetings at the NIH Bethesda campus, with interval quarterly meetings held in conjunction with the annual meetings of critical illness and injury professional societies.Lay Summary This grant will create a US Critical Illness and Injury Trials Group meeting. The Group will facilitate collaboration among experts with the goal of promoting clinical trials in the field of critical illness and injury. The success of the Group will be measured by the number of new grants funded to test hypotheses in clinical trails in the critically ill or injured.
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