DoD Multiple Sclerosis Pilot Clinical Trial Award
The MSRP Pilot Clinical Trial Award (PCTA) mechanism is being offered for the first time in FY15. The PCTA supports early-phase, proof-of-principle clinical trials to investigate hypothesis-based, innovative interventions that have the potential to result in a profound impact on management of MS symptoms. While therapeutic approaches proposed for testing through the PCTA must represent novel, hypothesis-based, â₏œoutside-the-boxâ₏ approaches for treating MS symptoms, they may include therapies already in clinical use, or undergoing clinical testing, for other diseases, provided that the proposed use for MS would lead to a major advancement for treating one of the disease symptoms. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform MS patient care. The PCTA will support clinical trials encompassing Phase 0, Phase I, or pilot Phase II for drugs or drug combinations, Class II or III for devices, or other types of trials that conduct early clinical testing of innovative approaches for MS symptoms. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider the Investigator-Initiated Research Award (W81XWH-15-MSRP-IIRA). The term â₏œhuman subjectsâ₏ is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed pilot clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Examples of acceptable studies include but are not limited to the following: â₏¢ Identification of an appropriate population for the proposed study â₏¢ Identification of the dosage, duration, and/or delivery strategy of an intervention â₏¢ Evaluation of the feasibility of the intervention in MS â₏¢ Evaluation of efficacy and safety The following are important aspects of submission for the PCTA: â₏¢ Pre-application is required; application submission is by invitation only. â₏¢ The application must include scientific rationale and/or preliminary data relevant to MS and the proposed study. â₏¢ The proposed intervention to be tested should offer significant potential impact on the management of MS symptoms. â₏¢ The application should demonstrate documented availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. â₏¢ The application should clearly describe the steps that will be taken to advance the intervention into the next stage of development following the conclusion of this award. â₏¢ Preclinical studies will not be supported by this mechanism. â₏¢ Investigational New Drug (IND) or Investigational Device Exemption (IDE) approvals, if applicable, must be in place before an award will be made. â₏¢ Clinical trials are expected to be initiated within 6 months of the award date. Funding from the PCTA must support a clinical trial and cannot be used for preclinical research or correlative studies. Principal Investigators (PIs) seeking funding for preclinical or correlative studies should refer to the FY15 MSRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number: W81XWH-15-MSRP-IIRA).
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
