DoD Gulf War Illness Clinical Trial Development Award

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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 GWIRP’s 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.

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