Opportunity Information: Apply for W81XWH 16 MSRP PCTA
Apply for W81XWH 16 MSRP PCTA
- The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Multiple Sclerosis Pilot Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Apr 15, 2016 and posted on Apr 15, 2016.
- Applicants must submit their applications by Aug 29, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The DOD Multiple Sclerosis Pilot Clinical Trial Award (PCTA), offered under the Department of Defense Multiple Sclerosis Research Program (MSRP), is a grant/cooperative agreement opportunity designed to fund early-stage, proof-of-principle clinical trials focused specifically on improving the management of multiple sclerosis (MS) symptoms. The central purpose is to move promising, hypothesis-driven symptom interventions into human testing at an early phase, generating the kind of real-world clinical evidence needed to justify larger, later-stage efficacy trials that could meaningfully change MS patient care. The program emphasizes interventions with the potential for a substantial impact on symptom management rather than incremental improvements, and it is positioned as a bridge between an innovative idea and a more definitive, larger clinical trial.
The award supports pilot clinical trials in early clinical development stages, including Phase 0, Phase I, or Phase II studies for drugs or drug combinations, and Class II or Class III device studies, as well as other early clinical testing formats that evaluate new approaches to addressing MS symptoms. A key point is that the approach must be novel and hypothesis-based for MS symptom treatment, but it does not have to be a brand-new therapy in the broader medical landscape. For example, an intervention already used clinically for another condition, or one currently being tested in other diseases, can still be responsive if its application to MS symptom management is innovative and would represent a major advancement for a particular MS symptom domain. The intent is to encourage smart repurposing and translation when it could create a meaningful leap forward for people living with MS.
This funding mechanism is strictly for clinical trials and cannot be used for preclinical research or for correlative studies that are not part of the trial itself. In other words, the funded work must involve prospectively accruing human participants and testing an intervention in those participants to measure outcomes tied to exploratory signals, safety, effectiveness, and/or efficacy. The opportunity uses a standard, broad definition of a clinical trial: a prospective study where an intervention (which can include drugs, devices, biologics, surgical procedures, rehabilitative modalities, behavioral interventions, or other approaches) is tested in human subjects with measurable outcomes that reflect a direct effect of that intervention on the participant. The announcement also clarifies that the term "human subjects" refers to the individuals recruited for or participating in the proposed pilot clinical trial, and it points applicants to a dedicated Human Subject Resource Document hosted on the eBRAP platform for additional guidance.
In terms of competitiveness and program scale, the opportunity notes that the PCTA mechanism was first offered in FY15, when 25 applications were received and 3 were recommended for funding, signaling a selective process. For the FY16 posting summarized here, the funding opportunity number is W81XWH-16-MSRP-PCTA and it was administered by DOD-AMRAA. It was categorized as a discretionary research and development funding opportunity (CFDA 12.420) with an unrestricted eligibility statement (open to any type of entity, subject to any additional eligibility clarifications in the full text). The original and current closing date listed was August 29, 2016, and the opportunity anticipated making approximately two awards. The listing shows an award ceiling of 0, which typically indicates the ceiling was not specified in the summary record and would need to be confirmed in the full announcement or associated program documentation.
Finally, the announcement draws a clear boundary between this clinical-trial-focused mechanism and earlier-stage work. Investigators who are aiming to conduct preclinical research on MS symptoms are directed instead to the MSRP Exploration - Hypothesis Development Award (W81XWH-16-MSRP-EHDA). Taken together, the PCTA is essentially a translational, early clinical testing mechanism meant to produce credible human data on innovative symptom interventions, building the scientific rationale needed to launch larger, more definitive trials that could transform symptom care for individuals with MS.
FAQs: DOD Multiple Sclerosis Pilot Clinical Trial Award (PCTA)
What is the DOD Multiple Sclerosis Pilot Clinical Trial Award (PCTA)?
The PCTA is a Department of Defense funding opportunity under the Multiple Sclerosis Research Program (MSRP) designed to support early-stage, proof-of-principle clinical trials focused specifically on improving the management of multiple sclerosis (MS) symptoms. It is intended to help move promising, hypothesis-driven symptom interventions into human testing and generate clinical evidence that can justify larger, later-stage trials.
What is the main goal of this award?
The main goal is to create a bridge between an innovative symptom-management idea and a more definitive, larger clinical trial. The award aims to produce credible human data (such as safety, exploratory signals, effectiveness, and/or efficacy outcomes) that supports progressing to larger efficacy trials that could meaningfully change MS symptom care.
Is this award focused on MS disease modification or MS symptom management?
Based on the opportunity description provided, the focus is MS symptom management. The program is centered on interventions intended to improve the management of MS symptoms rather than describing a disease-modifying scope.
What kinds of studies does the PCTA support?
The PCTA supports pilot clinical trials in early clinical development stages. Examples listed include Phase 0, Phase I, or Phase II studies for drugs or drug combinations, and Class II or Class III device studies. It may also support other early clinical testing formats that evaluate new approaches to addressing MS symptoms, as long as they meet the clinical trial definition used in the announcement.
What types of interventions can be tested?
The opportunity uses a broad clinical trial definition where the intervention can include drugs, devices, biologics, surgical procedures, rehabilitative modalities, behavioral interventions, or other approaches. The key is that the intervention is tested prospectively in human subjects with measurable outcomes reflecting the direct effect of the intervention.
Does the intervention have to be completely new?
No. The intervention must be novel and hypothesis-based for MS symptom treatment, but it does not have to be entirely new in the broader medical field. For example, a therapy already used for another condition, or being tested in another disease area, may still be responsive if its application to MS symptom management is innovative and represents a major advancement for a specific MS symptom domain.
What level of impact is the program looking for?
The program emphasizes interventions with the potential for a substantial impact on symptom management rather than incremental improvements. It is positioned to support approaches that could create a meaningful leap forward for people living with MS.
Is preclinical research allowed under this award?
No. This mechanism is strictly for clinical trials and cannot be used for preclinical research.
Are correlative studies allowed?
Correlative studies that are not part of the clinical trial itself are not supported by this mechanism. The funded work must be part of the trial and aligned with prospectively testing an intervention in human participants to measure relevant outcomes.
What does the program mean by a "clinical trial"?
The opportunity applies a standard, broad definition: a prospective study in which an intervention is tested in human subjects and produces measurable outcomes that reflect a direct effect of the intervention on the participant.
Does the trial need to prospectively accrue human participants?
Yes. The opportunity states that the funded work must involve prospectively accruing human participants and testing an intervention in those participants.
Who counts as "human subjects" for this opportunity?
"Human subjects" refers to the individuals recruited for or participating in the proposed pilot clinical trial.
Is there any additional guidance referenced for human subjects requirements?
Yes. Applicants are referred to a dedicated Human Subject Resource Document hosted on the eBRAP platform for additional guidance.
Is this opportunity a grant or a cooperative agreement?
It is described as a grant/cooperative agreement opportunity.
What is the funding opportunity number for the FY16 posting described?
The funding opportunity number provided is W81XWH-16-MSRP-PCTA.
Who administered this opportunity?
The FY16 posting summarized here was administered by DOD-AMRAA.
What CFDA number is associated with this opportunity?
The opportunity is listed under CFDA 12.420.
Who is eligible to apply?
The eligibility statement in the summary is unrestricted, meaning it is open to any type of entity, subject to any additional eligibility clarifications that may be included in the full announcement text.
How competitive is this award?
The opportunity notes that when the PCTA mechanism was first offered in FY15, 25 applications were received and 3 were recommended for funding, suggesting a selective process.
How many awards were anticipated for the FY16 opportunity?
The FY16 listing anticipated making approximately two awards.
What was the closing date listed for the FY16 opportunity?
The original and current closing date listed was August 29, 2016.
Is there an award ceiling (maximum funding amount) stated in the summary?
The listing shows an award ceiling of 0, which typically indicates the ceiling was not specified in the summary record and would need to be confirmed in the full announcement or associated program documentation.
If my project is preclinical and focused on MS symptoms, is there another MSRP mechanism mentioned?
Yes. Investigators aiming to conduct preclinical research on MS symptoms are directed to the MSRP Exploration - Hypothesis Development Award (W81XWH-16-MSRP-EHDA).
What is the PCTA intended to produce at the end of the project?
The intent is to produce early human clinical evidence (including safety and exploratory outcome signals and/or early indications of effectiveness/efficacy) that strengthens the rationale for launching larger, more definitive efficacy trials for MS symptom management.
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