U.S. Critical Illness and Injury Trials (USCIIT) Group
2009 CALL FOR CLINICAL PROPOSALS

Call for Clinical Proposals close date has been extended to September 30, 2009

The US Critical Illness and Injury Trials Group (USCIITG) promotes clinical research and the application of new data to improve outcomes for the critical ill or injured across the age (developmental) continuum. To this end, it aims to establish an inclusive, nationwide network of experts to review published data, establish national priorities, vet hypotheses, write clinical protocols, and generate pilot data. The success of the Trials Group is measured in part by the quality of the clinical proposals in development and the number of those proposals that compete successfully for federal funding.

Background

In response to the 2008 request for proposals, 18 Clinical Projects were presented at the inaugural meeting (November 18-19, 2008), providing a venue for investigators to propose research protocols that would benefit from USCIIT Group discussion. PLEASE NOTE THAT THE USCIIT GROUP CANNOT PROVIDE FUNDING OR MATERIAL RESOURCES. Instead, meeting attendees at the Fall (Bethesda), Winter (SCCM), and Spring (ATS) meetings provide feedback, volunteer service, collaborative input, promoting NIH grant submissions. As a few measures of success, approximately half of the 2008 Projects expanded clinical sites in response to attendee feedback, half have applied for NIH funding subsequent to the Fall meeting, and over half have started new projects with USCIIT Group investigators.

Consistent with the USCIIT Group Code of Conduct, the success of these interactions are based upon a cooperative model of information exchange. The approach is inclusive and aims to learn from all those present. Projects are expected to generate multidisciplinary "teams" that openly solicit input and encourage collaboration among investigators with similar ideas across institutions.

Current clinical projects are described on the USCIIT Group web site (http://www.usciitg.wustl.edu). Examples of hypothetical clinical proposals include but are not limited to the following:

• 1) Testing a hypothesis at multiple centers: A PI has convincing pilot data from a single institution suggesting that a new protocol/widget/drug may improve outcome/care for the critically ill or injured. Adequate power for a clinical trial of efficacy/effectiveness will require a large number of patients. USCIITG collaborations are sought to collect and analyze additional preliminary data and to apply for grant funding to test the hypothesis at multiple centers
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• 2) At a single institution, clinical equipoise exists for the use of an existing protocol/widget/drug. USCIITG collaborators are sought to conduct a national survey, which in turn will motivate submission of a grant application to test the effectiveness of the protocol/widget/drug A versus B.
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• 3) Results from a seminal study have been validated prospectively in two subsequent, independent reports indicating that a new protocol/widget/drug improves outcome in a subpopulation of the critically ill or injured. The protocol/widget/drug is easy/cheap (or difficult/expensive) and interest exists in determining how best to implement it in clinical practice (efficacy versus effectiveness). USCIITG input and collaborators are sought to generate new data, the analysis of which would be used to advise the community on dissemination of new research findings and implementation.

Submission Process

Clinical Proposals are limited to two pages in length (one-inch margins, 12-point font) and are submitted via a web-based tool at the USCIITG meeting website. Each proposal must provide the following information:

• Project title
• Project Director(s) (PI or co-PI’s)
• Collaborators and their institutions
• Background
• Hypothesis
• Research design or plan
• Available resources (internal or preliminary funding, technical support, etc.)
• Funding goals
• Intellectual property restrictions or concerns
• Expectations from USCIITG (expertise, meeting venues, etc.)

The submission process has been extended and will close at midnight EST, September 30, 2009. Proposals will be evaluated by the USCIITG Organizing Committee and ranked; the majority (if not all) Project Directors will be invited to present their hypotheses at poster presentations sessions at the Fall meeting, December 8-9, 2009. A couple of proposals will be selected for plenary presentations on December 8. Investigators will be notified of the status of their submission by October 22, 2009. Proposals that are similar in scope or focus may be grouped together. Small group discussions to support Projects will be held the afternoon of December 9. See the meeting agenda for more details.

Submit Your Clinical Proposals

Please submit your proposal here: Submit Proposal

NOTE: Subsequent USCIITG meetings will be held in Miami (Winter meeting held in conjunction with the Congress of the Society of Critical Care Medicine) and in New Orleans (Spring meeting held in conjunction with the American Thoracic Society International Conference). At these subsequent meetings, Project Directors (or a surrogate) should plan on presenting an Update for additional feedback and support.