The U.S. Department of Defense Fiscal Year 2010 Appropriation included $8 million for the Gulf War Illness Research Program (GWIRP) of the Congressionally Directed Medical Research Programs (CDMRP).
The GWIRP has released the following four program announcements planned for Fiscal Year 2010:
- Clinical Trial Award
- Innovative Treatment Evaluation Award
- Consortium Development Award
- Investigator-Initiated Research Award
Full Program Announcements, Application Instructions and deadlines are available on the CDMRP website: http://cdmrp.army.mil/funding/gwirp.htm .
The Synopsis Table with deadlines is also on the website: http://cdmrp.army.mil/funding/pdf/10gwirpreftable.pdf.
DoD Fiscal Year 2010 Gulf War Illness Research Program:
The FY2010 Gulf War Illness Research Program (GWIRP) challenges the scientific community to design high-impact research that will improve the health and lives of veterans who have Gulf War Illness (GWI). GWI is characterized by multiple diverse symptoms that typically include chronic headache, widespread pain, cognitive difficulties, debilitating fatigue, gastrointestinal problems, respiratory symptoms, and other abnormalities that are not explained by established medical diagnoses or standard laboratory tests.
The GWIRP focuses its funding on innovative projects that have the potential to make a significant impact on GWI. These may take the form of identification of objective indicators of pathology that distinguish ill from healthy veterans, or studies to understand the underlying pathobiology of GWI. The GWIRP encourages risk-taking research; however, all projects must demonstrate solid judgment and sound rationale.
Please forward to bio-life, clinical, immunology, molecular, pathology, epidemiology, environmental medicine, gastroenterology, occupational medicine, pain, toxicology, virology, - experimental therapeutics, endocrinology, and pharmacology scientists at the Temple University School of Medicine interested in Gulf War Illness, Chronic Fatigue Syndrome, Chronic Multi-Symptom Illness, Fibromyalgia Syndrome. You may disseminate this information to the widest possible audience using links, list serves, funding websites, newsletters, and forwarding this e-mail.
Award Mechanism Summaries:
The FY10 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Clinical Trial Award (CTA) and the Innovative Treatment Evaluation Award (ITEA).
The Clinical Trial Award is intended to support larger, more definitive (Phase II-III) clinical trials where preliminary evidence indicates the potential for substantial benefit for veterans with GWI.
In contrast, 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.
1. The GWIRP Clinical Trial Award mechanism is designed to support identification of effective interventions for GWI. Health outcomes of interest include effects of interventions on:
a. Global health measures, functional status
b. Symptom complexes (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities) individually and as they may interact with each other
c. Measurable clinical outcomes, biomarkers
d. GWI subgroups characterized by symptom or other clinical characteristics
Additional interesting aspects of the Clinical Trial Award include:
a. Preliminary/pre-clinical data are required indicating potential substantial benefit for veterans with GWI, but does not necessarily have to come from the GWI research field.
b. Independent investigators at all academic levels (or equivalent) are eligible to submit proposals.
c. Full applications will be invited based on pre-application screening.
d. Maximum period of performance is four (4) years. Maximum allowable funding for entire period of performance is $1,500,000 in direct costs plus allowable indirect costs.
2. The GWIRP Innovative Treatment Evaluation Award supports the initial evaluation of a treatment or intervention in early phase or pilot clinical trials (Phase II or I/II), and does not require preliminary data. The mechanism is designed to support the systematic evaluation of innovative treatment interventions not previously studied in ill Gulf War veterans, with the aim of improving their health and functional status. This award mechanism is intended to evaluate a broad scope of treatment approaches with potential for widespread, cost-effective application for GWI.
Additional interesting aspects of the Innovative Treatment Evaluation Award include:
a. Important aspects of the ITEA award are Innovation, Preliminary Data, Study Endpoints, GWI Case Definition, GWI Patient Access, IND Applications and Initiation of Trial. Please refer to the full Program Announcement for these aspects on Page 3, http://cdmrp.army.mil/funding/archive/10gwirpitea_pa.pdf.
b. Full applications will be invited based on pre-application screening.
c. A study protocol will be the main body of the application.
d. Local IRB submission or approval is not required at the time of submission to the ITEA.
e. Independent investigators at all academic levels (or equivalent) are eligible to submit proposals.
f. Maximum period of performance is three (3) years. Maximum allowable funding for entire period of performance is $450,000 in direct costs plus allowable indirect costs.
3.The GWIRP Consortium Development Award mechanism seeks to promote a major multi-institutional research effort conducted by leading Gulf War Illness researchers that specifically focuses on innovative approaches for:
- Identifying treatment
- Improving GWI definition and diagnostics
- Characterizing disease symptoms
- Understanding underlying pathobiology
This effort will be executed through two separate award mechanisms, the Consortium Development Award in FY10 and the Consortium Award in FY11. Proposals for the Consortium Development Award are being requested in this program announcement.
The Consortium Development Award is an infrastructure development mechanism that provides support to create a Coordinating Center and establish the necessary collaborations at potential Research Sites for the development of a multi-institutional GWI research effort.
Participants in this consortium should be scientists and/or clinicians who have made significant contributions to the field of Gulf War Illness research or who have specific expertise related to the multiple symptoms associated with GWI progression. Infrastructure development includes (but is not limited to) establishing appropriate collaborations, outlining an administrative management plan, developing research management and communication plans, and devising an intellectual property plan.
Additional interesting aspects of the Consortium Development Award include:
a. Consortium Development Award mechanism being offered for first time in FY2010.
b. Independent investigators at the Assistant Professor level (or equivalent) or higher are eligible to submit proposals.
c. The Coordinating Center should have extensive experience in developing and conducting multi-institutional research projects.
d. Maximum period of performance is one (1) year. Maximum allowable funding for entire period of performance is $200,000 in direct costs plus allowable indirect costs.
e. The Pre-application includes a Letter of Intent and application submission through Grants.Gov.
4. The GWIRP Investigator-Initiated Research Award mechanism supports research focusing on the complex of symptoms known as Gulf War Illness, improving its definition and diagnosis, characterizing disease symptoms, and better understanding its pathobiology. It is intended to encourage basic or clinical developmental research aimed at identification of objective measures to distinguish ill from healthy veterans (e.g., biomarkers) or elucidate potential treatment targets for GWI. Studies that characterize chronic effects of neurotoxic exposures encountered during the Gulf War (and at comparable dosage) are also acceptable. Particular areas of interest include research on objective indicators of biological processes, or abnormalities in GWI associated with:
- Central nervous system structure and function, in particular, the role of glial cells, astrocytes, and microglia in GWI symptomatology
- Central neuroinflammatory processes
- Autonomic nervous system function
- Immune parameters
- Indicators of chronic infection
- Gastrointestinal complaints/symptoms
- Genetic, genomic, proteomic, or metabolic characteristics
Additional interesting aspects of the Investigator-Initiated Research Award include
a. Proposals are not required to include preliminary data, however, preliminary data may be used to support the objectives of a proposal. This data does not necessarily have to come from the GWI research fields.
b. Investigators at all academic levels (or equivalent) are eligible to submit proposals.
c. Full applications will be invited based on pre-application screening.
d. Maximum period of performance is three (3) years. Maximum allowable funding for entire period of performance is $600,000 in direct costs plus allowable indirect costs.
Award Mechanism Deadlines
Required Pre-Applications are submitted through http://cdmrp.org and are due by 5:00 p.m. Eastern Time on May 14, 2010.
Invitation to Submit an Application: June 2010 (for all mechanisms with exception of Consortium Development Award which will not be screened at pre-application).
Applications are submitted through www.grants.gov and are due by 11:59 p.m. Eastern Time on August 4, 2010.