Defense Health Agency Contracting Activity - DHACA

Description

The MSRP PCTA mechanism was first offered in FY15. In FY15, 25 PCTA applications were received, and 3 were recommended for funding. 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 the management of MS symptoms. While therapeutic approaches proposed for testing through the PCTA must represent novel, hypothesis-based approaches for treating MS symptoms, they may include therapies already in clinical use, or undergoing clinical testing for other diseases, provided that their 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. Funding from the PCTA must support a clinical trial and cannot be used for preclinical research or correlative studies. This mechanism supports pilot clinical trials encompassing Phase 0, Phase I, or 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 patients 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 subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project addressing MS Symptoms should consider the Exploration - Hypothesis Development Award (Funding Opportunity Number: W81XWH-16-MSRP-EHDA). The term “human subjects” 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.

Who can apply

• Unrestricted

Contact

CDMRP Help Desk <br/>301-682-5507 <br/>help@eBRAP.org
help@eBRAP.org