Defense Health Agency Contracting Activity - DHACA

Description

The GWIRP Investigator-Initiated Research Award mechanism was first offered in FY06. Since then, 208 Investigator-Initiated Research Award applications were received, and 57 were recommended for funding. New for FY15: The GWIRP Investigator-Initiated Research Award contains explicit prescriptive language (see below) to guide applicants proposing investigations of potential biomarkers of GWI. The Investigator-Initiated Research Award is designed to promote new ideas in GWI research and establish proof of principle for further development in future studies. Applications are not required to include preliminary data; however, preliminary data may be used to support the objectives of an application. These data are not required to have come from the GWI research field. Applications not supported by preliminary data should be based on sound scientific rationale and may reflect clinical observations or seek to evaluate discoveries made in relation to other chronic multisymptom illnesses for their application in GWI. Regardless of the approach, the focus should be clearly on Veterans with GWI. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate the project’s potential impact on GWI. The Investigator-Initiated Research Award supports research focusing on the complex of symptoms known as GWI, improving the case definition and diagnosis of GWI, characterizing disease symptoms, and better understanding the pathobiology. The purpose of the award is to encourage basic through clinical research aimed at identification of objective measures (e.g., biomarkers) to distinguish healthy Veterans from those with GWI, or improve understanding of the pathobiology underlying symptoms associated with GWI. Studies that characterize chronic effects of neurotoxic exposures at dosages comparable to that encountered in-theatre during the Gulf War are of interest. Studies using animal models should focus on long-term and latent effects of toxic exposures to closely represent the current status of GWI patients. All studies using animal models should use an established model unless there is a compelling scientific justification for the development or use of a new model. Development of new animal models is discouraged. The Investigator-Initiated Research Award can also be used for testing of GWI-targeted pharmacologic agents in absorption, distribution, metabolism, and excretion (ADME) studies, and toxicology testing, including Investigational New Drug (IND)-enabling pharmacology/ toxicology testing. Preclinical development of non-pharmacological interventions is also acceptable. Applications Proposing Biomarker Research: The search for biomarkers of GWI is of interest to the GWIRP; however, GWI is a chronic, multisymptom illness resulting from exposures that occurred more than two decades ago. Applicants seeking to investigate biomarkers of GWI are strongly encouraged to employ one or more of the following approaches, which take into account confounding factors of biomarker investigations when applied to GWI populations, patient samples, and/or data: • Use of pre-existing GWI patient samples (and matched control samples) that have been evaluated to ensure artifacts of sample treatment or storage are known and controlled for; • Investigation of markers that have been identified in peer-reviewed scientific literature as having potential for diagnostic testing (e.g., markers of neural inflammation, mitochondrial dysfunction, hormonal imbalance, and others related to GWI pathobiology); • Validation of markers for GW-specific exposures independent of later events unrelated to GW deployment; • Focus on the identification of markers in subgroups that share symptomatology or on groups with known exposures to specific agents; • Investigative strategies recognizing the distinction between biomarkers of agent exposures, biomarkers of specific effects of agent exposures, and biomarkers of GWI; • For markers related to exposure, a wide survey of available GW exposure data should be performed. Investigation involving derivation of markers from animal models does not address the intent of the biomarker focus area under this award.

Who can apply

• Unrestricted

Contact

CDMRP Help Desk <br/>301-682-5507
help@eBRAP.org