
CALL FOR CLINICAL PROPOSALS
Submission closes at 11:00 pm EDT, October 15, 2008.
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 will be measured in part by the number of grant applications funded to study the critically ill or injured.
Background
The inaugural Program for the November meeting (afternoon, Nov 18) provides a plenary session for investigators to present clinical proposals that would benefit from Trials Group discussion. PLEASE NOTE THAT THE TRIALS GROUP CANNOT PROVIDE FUNDING OR MATERIAL RESOURCES. Instead, meeting attendees will provide feedback, volunteer service, collaborative input, etc. Consistent with the Trials Group Code of Conduct, the success of this interaction is based upon a cooperative model of information exchange. The approach is inclusive and aims to learn from all those present. As the meeting is organizational, we expect that multidisciplinary “teams” will form that openly solicit input and encourage collaboration among investigators with similar ideas across institutions.
Examples of clinical proposals and the process may 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
Clinical Proposals are limited to two pages in length. Each proposal must
provide the following information:
1. Project title
2. Project Director(s) (PI or co-PI’s)
3. Collaborators and their institutions
4. Background
5. Hypothesis
6. Research design or plan
7. Available resources (internal or preliminary funding, technical support,
etc.)
8. Funding goals
9. Intellectual property restrictions or concerns
10. Expectations from USCIITG (expertise, meeting venues, etc.)
The submission process will close at 11:00 pm EDT, October 15, 2008. Proposals will be evaluated by the USCIITG Organizing Committee and ranked. Investigators will be notified of the status of their submission by October 27, 2008. Invitations will be issued to present at the USCIITG inaugural meeting on November 18, 2008. Proposals that are similar in scope or focus may be grouped together. Small group discussions to support Projects will be held the afternoon of November 19, 2008. See the meeting agenda for more details.