The Department of Defense (DoD) Gulf War Illness Research Program (GWIRP) offers the Clinical Trial Development Award (CTDA), a one-year grant specifically supporting essential planning and preparatory activities for future Phase II or Phase III clinical trials, or device trials. This initiative enables investigators to undertake critical pre-trial work, including developing comprehensive clinical protocols and experimental designs, composing the research team, initiating collaborations, and planning recruitment strategies for Gulf War veterans. Additionally, it supports establishing data collection/management procedures, developing statistical and safety monitoring plans, and finalizing FDA Investigational New Drug (IND)/Investigational Device Exemption (IDE) applications. The CTDA is not for collecting preliminary data; applicants must have an established rationale. Its primary purpose is to prepare a solid foundation for subsequent clinical research or commercialization.
Opportunity ID: 234614
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-13-GWIRP-CTDA |
| Funding Opportunity Title: | DoD Gulf War Illness Clinical Trial Development Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 14, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Sep 18, 2013 |
| Current Closing Date for Applications: | Sep 18, 2013 |
| Archive Date: | Oct 18, 2013 |
| Estimated Total Program Funding: | $320,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The GWIRP Clinical Trial Development Award (CTDA) mechanism was offered for the first time in FY11. The CTDA is intended to support planning activities necessary for the future conduct of a Phase II or Phase III clinical trial (or a trial of devices in U.S. Food and Drug Administration [FDA] classes I-III), since these activities usually represent a significant expenditure of time and effort. The CTDA is a 1-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. Applications must demonstrate that the rationale for the proposed clinical trial has already been clearly established, with appropriate supportive preliminary data. Clinical trial developmental activities allowed under a CTDA may include, but are not limited to: Developing the clinical protocol and experimental design Composing the research team and initiating collaborations necessary for the future clinical trial, and developing training procedures, as applicable Investigating potential intellectual or material property issues, as applicable Initiating access to an ill Gulf War veteran population and planning a recruitment strategy Developing quality control/assurance procedures Developing data collection/data management procedures Developing a data analysis/statistical plan Assessing potential issues regarding test article purity and formulation Developing a safety monitoring plan Determining a process for finalizing an FDA Investigational New Drug (IND)/ Investigational Device Exemption (IDE) application, if applicable Developing a transition plan with associated resources and collaborations to continue to the next phase of research or commercialization 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 GWIRPs Investigator-Initiated Research Award, aimed at basic research for GWI, 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. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 234614 Full Announcement-1 -> gwirp_fy13 ctda pa_gg.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk 301-682-5507 Email: help@cdmrp.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00177832 | May 14, 2013 | Sep 18, 2013 | View |
Package 1
Mandatory forms
234614 RR_SF424_1_2-1.2.pdf
234614 PerformanceSite_1_4-1.4.pdf
234614 RR_Budget-1.1.pdf
234614 RR_KeyPersonExpanded_1_2-1.2.pdf
Optional forms
234614 RR_SubawardBudget30-1.2.pdf
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