DoD FY11 Gulf War Illness Innovative Treatment Evaluation Award

Post Date

April 27th 2011

Application Due Date

August 24th 2011

Funding Opportunity Number

W81XWH-11-GWIRP-ITEA

CFDA Number(s)

12.420

Funding Instrument Type(s)

Cooperative Agreement
Grant

Funding Activity Categories

Science and Technology and other Research and Development

Number of Awards

2

Eligibility Categories

Unrestricted

Funding

• Estimated Total Funding:

  $1440000

• Award Range:

  $0 - $0

Grant Description

The FY11 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 Innovative Treatment Evaluation Award described in this Program Announcement/Funding Opportunity is intended to support the initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials (Phase II or I/II, devices in FDA Class I-III), and does not require preliminary data. In contrast, the CTA supports the evaluation of interventions in larger, more definitive clinical trials (Phase II or III), where preliminary and pre-clinical evidence indicates the potential for substantial benefit for veterans with GWI. (For more information about the CTA, see http://cdmrp.army.mil/funding/gwirp.htm). The ITEA mechanism was first offered in FY09. Since then, 10 ITEA applications have been received, and 4 have been recommended for funding. The ITEA supports the early systematic evaluation of innovative treatment interventions with the potential to impact the health and lives of veterans with GWI. The results of preliminary studies funded by this award can provide proof of principle data, and support future development of broader efficacy studies of the proposed interventions. Innovation is an important component of the ITEA. An application may demonstrate innovation not only by investigating a novel therapeutic approach for GWI, but also by studying a treatment that may have been utilized for other chronic multi-symptom illnesses, but has not yet been studied in ill Gulf War veterans. For example, a pharmacological treatment or nutritional supplement suggested by previous research to be beneficial for fibromyalgia or chronic fatigue syndrome could be evaluated in veterans with GWI under the ITEA. However, the focus of the research must be clearly on GWI and not on another disease process. This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for widespread 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. Also of interest are interventions based on biological alterations identified in veterans with GWI. All studies involving interventions, regardless of design, are considered clinical trials. Health outcomes of interest for the proposed trial should include effects of interventions on: ╔к_ Global health measures (biomarkers) and/or functional status ╔к_ Improvements in symptom complexes (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities, sleep difficulties) individually and as they may interact with each other ╔к_ GWI subgroups characterized by symptom or other clinical characteristics Studies whose principal focus is on treatment of psychiatric conditions, including Post-Traumatic Stress Disorder (PTSD), will not be funded under this Program Announcement/Funding Opportunity. While Gulf War veterans are affected by Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig╔к_s disease), at twice the rate of veterans who did not serve in the Gulf War, the GWIRP will not accept proposals focusing on ALS research. The Office of the Congressionally Directed Medical Research Programs (CDMRP) is offering a separate ALS Research Program in FY11 (see http://cdmrp.army.mil/alsrp). Applications must clearly indicate how GWI cases, including any targeted illness subgroups, will be defined for purposes of the study. Principal Investigators (PIs) must provide a published case definition they intend to use to define their GWI population. Any case definition must recognize the multi-symptom nature of GWI. NOTE: The 2008 report of the Research Advisory Committee on Gulf War Veterans╔к_ Illnesses, Gulf War Illness and the Health of Gulf War Veterans, provides information on GWI case definitions (pp. 29-30, p. 57), previous treatment research in Gulf War veterans (pp. 36-39), and treatment research related to other multisymptom conditions (pp. 285-287). The report is available online at: http://www1.va.gov/RAC-GWVI Given the innovative nature of the ITEA, applications are not required to include preliminary data. However, if provided, preliminary data do not necessarily have to come from the GWI research field. Whether or not preliminary data is included in the application, the proposed research project should be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. If there is significant preliminary and preclinical data reflecting considerable development of a treatment with applicability to GWI, the proposal would not be deemed innovative in keeping with the intent of the ITEA. In this case, investigators are encouraged to apply to the GWIRP CTA, which supports Phase II or Phase III clinical trials http://cdmrp.army.mil/funding/gwirp.shtml). Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. PIs seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term ╔к_human subjects╔к_ is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. PIs must clearly specify which type of clinical trial is being proposed: Phase II or Phase I/II for drug trials, Class I-III for device trials, or a description of other innovative trial designs. For descriptions of each type of clinical trial, please refer to the FDA 21CFR 312.21 (link), www.clinicaltrials.gov, or the NIH PH398 Instructions (p.III-26). For more information on clinical research, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms. Retrospective or non-interventional study designs are not considered clinical trials and should be submitted to the FY11 GWIRP Investigator-Initiated Research Award (see http://cdmrp.army.mil/funding/gwirp). If the study proposed involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for its investigational use then an Investigational New Drug (IND)application to the FDA may be required and must be submitted to the FDA prior to the grant submission. If the proposed study involves an Investigational Device that has not been approved or cleared by FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If applicable, the IDE application must be submitted prior to the grant submission. The Government reserves the right to withdraw funding if the documented status of the IND or IDE has not been obtained within 6 months of the award date. The following are important aspects of submission for the ITEA: ╔к_ The proposed clinical trial is expected to begin no later than 12 months after the award date. ╔к_ It is expected that the intervention, drug, or device to be used in the proposed trial will be available in sufficient quantities and ready for clinical trials at the time that the award is made. ╔к_ PIs must demonstrate availability of and access to a suitable Gulf War veteran population that will support a meaningful outcome for the study. Discuss how accrual goals will be achieved, and how standards of care may impact the study population. PIs are encouraged to collaborate with an investigator who has demonstrated access to a population of ill and healthy Gulf War veterans, particularly investigators within the U.S. Department of Veterans Affairs. ╔к_ Clearly articulate the statistical analysis plan, as applicable to the research design. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study. ╔к_ Discuss the potential impact of the study results for ill Gulf War veterans. ╔к_ Include a study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual, as appropriate to the study design. ╔к_ Demonstrate institutional support.

Contact Information

• Agency

  Department of Defense

• Office:

  Dept. of the Army -- USAMRAA

• Agency Contact:

  301-682-5507

• Agency Mailing Address:

  CDMRP Help Desk

• Agency Email Address:

  help@cdmrp.org