OpportunityTitle: DoD Gulf War Illness Clinical Trial Development Award
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: &#149; Developing the clinical protocol and experimental design &#149; Composing the research team and initiating collaborations necessary for the future clinical trial, and developing training procedures, as applicable &#149; Investigating potential intellectual or material property issues, as applicable &#149; Initiating access to an ill Gulf War veteran population and planning a recruitment strategy &#149; Developing quality control/assurance procedures &#149; Developing data collection/data management procedures &#149; Developing a data analysis/statistical plan &#149; Assessing potential issues regarding test article purity and formulation &#149; Developing a safety monitoring plan &#149; Determining a process for finalizing an FDA Investigational New Drug (IND)/ Investigational Device Exemption (IDE) application, if applicable &#149; Developing a transition plan with associated resources and collaborations to continue to the next phase of research or commercialization &#149; 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&#146;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.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;301-682-5507