OpportunityTitle: DoD Gulf War Illness Clinical Trial Development Award
Description: The GWIRP Clinical Trial Development Award (CTDA) mechanism is offered for the first time in FY11. The CTDA is intended to support planning activities necessary for the conduct of a Phase II or Phase III clinical trial (or a trial of devices in FDA classes I-III), since these activities usually represent a significant expenditure of time and effort. The CTDA is a one-year grant intended to allow investigators time to undertake preparatory activities and have the study rationale for a future clinical trial scientifically reviewed. The CTDA is not intended for the collection of preliminary data or the conduct of pilot studies to support the rationale for a future clinical trial. Clinical trial developmental activities allowed under a CTDA may include, but are not limited to: &#239;&#191;&#189; Developing the clinical protocol and experimental design &#239;&#191;&#189; Composing the research team and initiating collaborations necessary for the future clinical trial, and developing training procedures, as applicable &#239;&#191;&#189; Investigating potential intellectual or material property issues, as applicable &#239;&#191;&#189; Initiating access to an ill Gulf War veteran population and planning a recruitment strategy &#239;&#191;&#189; Developing quality control/assurance procedures &#239;&#191;&#189; Developing data collection/data management procedures &#239;&#191;&#189; Developing a data analysis/statistical plan &#239;&#191;&#189; Assessing potential issues regarding test article purity and formulation &#239;&#191;&#189; Developing a safety monitoring plan &#239;&#191;&#189; Determining a process for finalizing a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) / Investigational Device Exemption (IDE) application, if applicable &#239;&#191;&#189; Conducting other preparatory activities needed to support the future clinical trial These activities do not involve the collection of data supported by traditional investigator initiated research awards. Investigators interested in generating proof of principle data should consider the GWIRP&#239;&#191;&#189;s Investigator-Initiated Research Award, aimed at basic research for Gulf War Illness, or the Innovative Treatment Evaluation Award, which supports the initial evaluation of a treatment or intervention in small, early phase or pilot clinical trials (Phase II or I/II). For information about these award mechanisms, see http://cdmrp.army.mil/funding/gwirp.htm. Clinical trials supported by the GWIRP must recruit appropriately-defined ill Gulf War veteran cohorts. Therefore, PIs applying to the CTDA must provide a published case definition they intend to use to define their GWI population. Any case definition must recognize the multisymptom nature of GWI. NOTE: The 2008 report of the Research Advisory Committee on Gulf War Veterans&#239;&#191;&#189; 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 multi-symptom conditions (pp. 285-287). The report can be found online at http://www1.va.gov/RAC-GWVI. Investigators awarded a CTDA are expected to apply to the GWIRP&#239;&#191;&#189;s Clinical Trial Award in the program year following completion of the CTDA (i.e. FY11 CTDA awardees would apply for an FY13 or FY14 Clinical Trial Award, if that award is offered). The FY13 (or FY14) CTA application would include the results of the completed CTDA. Applications for an FY13 (or FY14) Clinical Trial Award, if offered, will only be accepted from investigators awarded an FY11 CTDA. However, award of an FY11 CTDA is in no way an assurance of funding for a future Clinical Trial Award. The funding of FY13 (or FY14) Clinical Trial Awards will be contingent upon the availability of federal funds for the program. The GWIRP Clinical Trial Award supports Phase II or Phase III (or FDA device class I-III) clinical trials of treatments with the potential to have a significant impact on the health and lives of veterans with GWI. The Clinical Trial Award requires that an IND or IDE application, if applicable, must be submitted prior to Clinical Trial Award application submission. Thus, investigators would be expected to use the CTDA period to initiate the IND/IDE application process. Please note that all Department of Defense (DOD)-funded research involving human subjects and human anatomical substances must be reviewed and approved by the US Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protections Office (HRPO), in addition to the local IRB of record. For more information about clinical trials and human subject research requirements, refer to the General Application Instructions, Appendix 5, D. The GWIRP Clinical Trial Award application requires extensive descriptions of clinical trial components. CTDA applicants are encouraged to reference the GWIRP FY11 Clinical Trial Award Program Announcement to become familiar with these requirements and to help direct activities during the CTDA period. The GWIRP FY11 Clinical Trial Award Program Announcement can be accessed at http:/cdmrp.army.mil/funding. Each CTDA application can only request support for preparations for a single clinical trial. However, investigators may submit more than one CTDA application supporting preparations for different clinical trials.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: 301-682-5507