DoD Gulf War Illness Clinical Trial Development Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Gulf War Illness Clinical Trial Development Award

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 (...

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Award $0 Deadline 5414 days ago Location Alabama Type grant Level Federal Closed posted May 5, 2011
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$640,000.
  • Next deadline: August 24, 2011.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Award amount
$0
Deadline
5414 days ago
Aug 24, 2011
Total pool
$640k

About this opportunity

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: � 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 a Food and Drug Administration (FDA) Investigational New Drug (IND) / Investigational Device Exemption (IDE) application, if applicable � 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�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/ 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� 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�s Clinical Trial Award in the program year following completion of the CTDA ( 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.

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Geographic eligibility

  • Alabama
  • Alaska
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  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
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  • Georgia
  • Hawaii
  • Idaho
  • Illinois
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  • District of Columbia

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Citation details

Source systemgrants.gov
Source ID91833
PostedMay 5, 2011

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