DoD Gulf War Illness Clinical Trial Development Award
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.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
