Defense Health Agency Contracting Activity - DHACA

Description

The FY15 GWIRP is offering two award mechanisms to evaluate potential interventions for GWI: the Innovative Treatment Evaluation Award and the Clinical Trial Award. The Innovative Treatment Evaluation Award, described in this Program Announcement, supports the initial evaluation of a treatment or intervention in early phase or pilot clinical trials (Phase 0, I, or I/II), and does not require preliminary data. These trials will hereafter collectively be referred to as “pilot clinical trials.” In contrast, the Clinical Trial Award is intended to support larger, more definitive (Phase II-III, U.S. Food and Drug Administration [FDA] device class I-III) clinical trials. (For information about the Clinical Trial Award, see http://cdmrp.army.mil/funding/gwirp.shtml.) The Innovative Treatment Evaluation Award mechanism was first offered in FY08. Since then, 42 Innovative Treatment Evaluation Award applications have been received, and 15 have been recommended for funding. The Innovative Treatment Evaluation Award mechanism supports the early systematic evaluation of innovative interventions with the potential to impact the health and lives of Veterans with GWI. The results of preliminary studies funded by this award should have the potential to provide clinical proof-of-principle data and support future development of broader efficacy studies of the proposed interventions. Innovation is an important component of the Innovative Treatment Evaluation Award. 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 multisymptom illnesses, but has not yet been studied in Veterans with GWI. 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 Innovative Treatment Evaluation Award. However, the focus of the research must be clearly on GWI (and Veterans of the 1990-1991 Gulf War) and not on another disease process or Veteran cohort. Given the emphasis on innovation in the Innovative Treatment Evaluation Award, applications are not required to include preliminary data. If preliminary data are provided, the data do not necessarily have to come from the GWI research field. Whether or not preliminary data are 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. Trials of treatments or interventions for which considerable preliminary and/or preclinical data have been developed should be proposed under the Clinical Trial Award (see http://cdmrp.army.mil/gwirp/default.shtml). This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for application to GWI. Treatment approaches may include pharmacologic or other physiological interventions, including conventional, alternative, or complementary (combination of alternative and conventional) 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. The Innovative Treatment Evaluation Award supports execution of clinical trials with the potential to have a significant impact on the health and lives of Veterans with GWI. Health outcomes of interest should include improvements in overall functional status or in symptom complexes (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities, sleep difficulties and others) individually and/or as they may interact with each other.

Who can apply

• Unrestricted

Contact

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