Instructions

U.S. Critical Illness and Injury Trials (USCIIT) Group
2009 CALL FOR CLINICAL PROPOSALS
The submission process will close at midnight EST, 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

The background can be no more than 1,000 words.

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 Annual 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://public.wudosis.wustl.edu/USCIITG/default.aspx).   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

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.

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

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 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 5, 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.  

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

ONLINE SUBMISSION NOTES:

This section contains information to guide you through the online submission process. We recommend that you print this page and use it as a reference during the process.

1. Click the button on the left side of the screen and complete each section. Be sure to carefully follow the instructions within each section. When the section is completed, you will see a green exclamation point (!).
2. Save your work by clicking "Save" on each page. This does not submit your proposal for review. Be sure to save your work before logging off the site.
3. You can log off at any time without submitting your proposal. You may return to the site at any time prior to the submission deadline to edit your proposal, as long as you do not submit the proposal. If you give your username and password to another person, they will have access to edit all proposals you have not submitted.
4. Verify that your proposal is correct by clicking "Preview".
5. Print out and proofread the proposal preview to verify that it is correct before completing the submission.
6. Click on "Submit" ONLY when you have completed your proposal and it is in final form.