Through the FY09 Gulf War Illness Research Program (GWIRP), the Department of Defense's Congressionally Directed Medical Research Programs (CDMRP) solicits applications for the Innovative Treatment Evaluation Award (ITEA). The ITEA supports the initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials (Phase II or I/II), and does not require preliminary data. [Note: All studies involving interventions, regardless of design, are considered clinical trials.]
The Innovative Treatment Evaluation Award contains the following key mechanism elements:
- Supports exploratory or small-scale studies evaluating potential treatments not previously studied in GWI.
- Pilot Phase II or Phase I/II trial combinations are permitted.
- Preliminary data are not required, though proposed study must be supported by logical rationale.
- Studies having pre-liminary/preclinical data should submit to the Clinical Trial Award (see below).
Jun. 17, 2009 (REQUIRED pre-application - letter of intent);
Sep. 9, 2009 (invited full application).
The official announcement and description of this opportunity may be found on the funding agency's website:
Areas of Interest:
This award mechanism is intended to evaluate a broad scope of treatment approaches with potential for widespread, cost-effective application for GWI. Treatment approaches may include pharmacologic or other physiological interventions, including either conventional or complementary treatments, or combinations of these approaches. A variety of experimental and non-experimental study designs are acceptable under this award mechanism. The proposed study design will depend on the specific treatment or intervention to be assessed, resources available to clinical investigators, and the level of evidence currently available to support the proposed treatment for GWI. Examples of potential prospective designs may include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, a combination of these, or other innovative prospective methods.
Projects of interest include innovative treatment approaches currently in clinical use that have not been systematically evaluated for effectiveness in treating GWI but may have been evaluated in conditions with similarities to GWI. Also of interest are interventions based on biological alterations identified in veterans with GWI. Thus, the GWIRP will accept proposals not only for early pilot clinical trials supported by preliminary data but also for those based on sound scientific rationale without support from preliminary data.
Medical - Clinical Science; Medical - Translational.
All individuals, regardless of ethnicity, nationality, or citizenship status, may apply as long as they are employed by, or affiliated with, an eligible institution. Eligible applicants for the Investigator-Initiated Research Award are independent investigators at all academic levels).
The maximum funding for the award is $450,000 for direct costs. The maximum period of perfornance is three years.
Numerical value: $450,000
Funding Agency Contact:
Department of Defense
US Army Medical Research and Materiel Command, Commander
ATTN: MCMR-ZB-C (OC05-PA)
1077 Patchel Street (Building 1077)
Fort Detrick MD 21702-5024