The federal VA has internally announced the following funding opportunity for research awards for new treatments for Gulf War Veterans' Illnesses.
Additional information is available at the end of this article, which summarizes key information about this Request for Applications.
Opportunity Number: CX-09-007: CSR&D Award for Research on New Treatments for Gulf War Veterans' Illnesses
Agency: Department of Veterans Affairs. Applications may be submitted from any VA medical center with an active research program.
Opening Date: 06/15/2009
Closing Date: Not later than 11 p.m. EST on 07/15/2009, submitted electronically (no paper applications accepted) via eRA Commons.
Peer Review Date(s): anticipated review in August or September, 2009.
Earliest Anticipated Start Date: October 1, 2009.
Expiration Date: December 31, 2010
APPLICATION INSTRUCTIONS OVERVIEW:
1. The most recent version of the VA-ORD Application Guide for SF424 (R&R) can be found at the following URL: http://vaww.research.va.gov/funding/electronic-submission.cfm
2. RFAs for electronic submission of research proposals to VA-ORD can be found at the following URL: http://vaww.research.va.gov/funding/rfa.cfm
3. Download Application Package from the following URL: http://apply07.grants.gov/apply/opportunities/packages/oppCX-09-007.pdf
Veterans who served in the Gulf War in 1991 demonstrate increased incidence of several health conditions, including fibromyalgia, chronic fatigue syndrome, skin abnormalities and gastrointestinal disturbances (1). Fibromyalgia syndrome afflicts sufferers with persistent, widespread pain. Chronic fatigue syndrome leaves sufferers with a disabling loss of energy; the two conditions may be present within a single individual. Some ill Gulf War Veterans have reported chronic multiple symptom ilnesse(s) that do not meet case definition for either of these conditions.
There are currently two FDA-approved drugs [91outcomes Editor's Note: Actually, there are three -- the third is Savella (milnacipram HCI), another SNRI, approved by the FDA in January 2009. A fourth, sodium oxybate (Xyrem), has favorable ongoing research.] for treatment of fibromyalgia – pregabalin (Lyrica) and duloxitine (Cymbalta), a selective serotonin and norepinephrine reuptake inhibitor (SNRI). While it appears that both drugs have been employed to treat veterans suffering from fibromyalgia, it is not clear whether response rates are similar to those observed in treatment studies based on the general population. Similarly, there does not appear to be information on the relative efficacy of the two drugs within the Gulf War population, no information on whether a Gulf War Veteran who fails to respond adequately to one drug has a significant likelihood of benefitting from a switch to the other, and no information on whether the use of multiple drugs in combination can augment treatment effectiveness.
1 Eisen SA, Kang HK, Murphy FM, Blanchard MS, Reda DJ, Henderson WG, Toomey R, Jackson LW, Alpern R, Parks BJ, Klimas N, Hall C, Pak HS, Hunter J, Karlinsky J, Battistone MJ, Lyons MJ; Gulf War Study Participating Investigators. Gulf War veterans' health: medical evaluation of a U.S. cohort. Ann Intern Med. 142(11):881-890, 2005.
Other recent treatment trials have examined the use of exercise [sic]
The Clinical Sciences Research and Development Service solicits submissions of applications for studies that address the effectiveness in the Gulf War veteran population of these drugs, and of other treatments for which a plausible biological basis for anticipated efficacy can be established. Successful applications will propose a scientifically meritorious, controlled clinical trial or epidemiological investigation which addresses treatment of veterans who served in the theater of operations during the 1991 Gulf War with chronic multisymptom illnesses compared with fibromyalgia and/or chronic fatigue syndrome. Applications not employing appropriate populations of Gulf War Veterans will not be considered for funding.
Recent trials for treatment of chronic pain in fibromyalgia have included: transcranial magnetic stimulation of the motor cortex, melatonin, and nabilone. Proposals to test FDA-approved therapies for other chronic multisymptom illnesses in a Gulf War Veteran population may be submitted.
Proposals may also include identification or use of biomarkers (i.e., genetic, neuroendocrine, immunological, biochemical, physiological, etc.) that either predict or explain differences in response to the proposed treatment(s). Biomarker studies without an accompanying treatment trial will not be considered for funding.
The Merit Review Award Program is an intramural funding mechanism to support investigator-initiated research conducted by eligible VA-ORD investigators at VA medical centers or VA-approved sites. Merit Review Awards are one of CSR&D’s primary mechanisms for funding behavioral, epidemiological, and clinical research on disorders and diseases of importance to the health of veterans. The CSR&D purview includes interventional, experimental, and/or observational studies involving human subjects.
Proposals involving collection of medical histories, administering survey instruments or questionnaires, or performing medical procedures (including biopsies) or treatment regimens should be submitted to CSR&D. All clinical trials should be submitted to CSR&D, even if some specific aims in the proposal meet the purview of Biomedical Laboratory Research and Development (BLR&D). Proposals electronically submitted to CSR&D through Grants.gov will be peer-reviewed by Merit Review Panels (MRPs) to provide the Director of CSR&D with evaluations of the quality of the research proposed and make recommendations on scientific merit, budgets, and funding durations.
Budget of Merit Review Awards: Proposals submitted under this RFA must be at least $50,000 per year, exclusive of equipment and non-clinician PD/PI salary, and for a minimum duration of 2 years. Budgets are capped due to budgetary constraints. Currently, the recurring budget (not including contact PD/PI salary and equipment) may not exceed $1,000,000 for the entire award period. Equipment request are limited to $50,000 for the entire award period and may not include patient care devices. Pilot projects may be submitted with a maximum budget of $100,000 per year. Only the salary for the contact PD/PI identified in Box 15 of the SF424 (R&R) Cover Component is excluded from the budget cap.
The research design is expected to be appropriate and efficient, with all budget categories well justified. In planning project budgets, applicants are reminded to adhere to ORD guidelines regarding allowable use of research funds for specific items.
CONTACTS FOR ADDITIONAL INFORMATION
VA encourages scientific/programmatic inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Reminder: Questions concerning electronic submission should be directed to Grants.gov or eRA Commons.
1. Scientific/Research Contacts: Inquiries related to Merit Review submission or review should be directed to the Chief of Program Review. The PD/PI may contact the appropriate portfolio managers with questions specifically related to scientific issues raised in the summary statement for a reviewed proposal or the scientific content of a proposal to be submitted. The associate chief of staff (ACOS) for research and development (R&D) should make all other contacts with CSR&D staff at VA central office (VACO), including questions relating to budget modifications noted in the summary statement. Contact information for Scientific Review Administrators for individual MRP may be found at http://vaww.research.va.gov/funding/electronic-submission.cfm
2. Financial Management Contact(s): Sara Clark at Sara.Clark@va.gov