Opportunity Information: Apply for PAR 15 278
Apply for PAR 15 278
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jun 15, 2015 and posted on Jun 15, 2015.
- Applicants must submit their applications by Apr 5, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. See full announcement for details.
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Opportunity Summary:
The NINDS Exploratory Clinical Trials for Small Business (R42) opportunity (Funding Opportunity Number PAR 15-278) was a National Institutes of Health (NIH) grant program designed to support small businesses that want to run investigator-initiated, exploratory clinical trials in areas that fit the mission of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, it was meant to give U.S. small business concerns a clear pathway to move a neuroscience-related product into human testing when the work rises to the level of a clinical trial and is still in an early, exploratory stage. The core idea is translational: take a promising intervention or tool and generate initial human data that can guide later, larger, more definitive trials and, ultimately, product development and commercialization.
The scope of what could be tested under this FOA was broad as long as it aligned with NINDS goals. Projects could evaluate drugs and biologics, medical devices, and diagnostics, as well as non-pharmacologic interventions such as surgical approaches, behavioral therapies, or rehabilitation strategies. That breadth matters because neurological disorders often require solutions that go beyond traditional pharmaceuticals, including neurotechnology, imaging or biomarker-based diagnostics, and structured therapy or rehab programs. The emphasis on "products" signals that applicants were expected to be developing something with a plausible path toward deployment in real-world clinical care or use, not just answering a basic science question.
This funding used the Small Business Technology Transfer (STTR) mechanism and specifically targeted the R42 activity code, which is the STTR Phase II award. Under the terms described, only STTR Phase II and STTR Fast-Track applications were supported. A standalone STTR Phase I application was not eligible under this program; Phase I was only allowed if it was bundled into a Fast-Track submission. That structure reflects the purpose of the FOA: it was not aimed at very early feasibility work in isolation, but rather at projects that were ready to move efficiently into a Phase II development effort and support an exploratory clinical trial. In other words, applicants generally needed to be beyond concept-level research and closer to a stage where human testing was scientifically and operationally justified.
Eligibility was limited to United States small business concerns. The listing identifies the applicant category as small businesses and notes that only U.S. SBCs could apply, consistent with STTR program rules. The program did not require cost sharing or matching funds, which can be important for smaller companies that may not have substantial non-dilutive capital available. The award instrument was a grant and the activity category was health, listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
From an administrative standpoint, this FOA was posted on June 15, 2015, and ultimately closed on April 5, 2018, with an archive date of May 6, 2018. That means it functioned as a time-limited solicitation rather than an open-ended mechanism. The sponsoring agency was NIH, and the relevant institute for program fit and scientific direction was NINDS. The full announcement was hosted on the NIH grants guide website (the link provided in the source), and NIH Office of Extramural Research (OER) support contacts were listed for technical access issues.
Overall, PAR 15-278 was essentially a targeted NIH/NINDS pathway for U.S. small businesses working with research partners under the STTR model to conduct early-stage clinical trials of neurological interventions or tools. It prioritized translational, product-oriented studies, allowed a wide range of therapeutic and diagnostic modalities, and focused support on Phase II and Fast-Track projects that were positioned to move into exploratory clinical evaluation rather than remaining at the preclinical or concept demonstration stage.
FAQs: NINDS Exploratory Clinical Trials for Small Business (R42) (PAR 15-278)
What is PAR 15-278 (NINDS Exploratory Clinical Trials for Small Business - R42)?
PAR 15-278 was a National Institutes of Health (NIH) funding opportunity created by the National Institute of Neurological Disorders and Stroke (NINDS) to support U.S. small businesses conducting investigator-initiated, exploratory clinical trials. Its purpose was to help move neuroscience-related products into early human testing to generate initial clinical data that can inform later, larger trials and product development.
What type of NIH award mechanism did this program use?
This opportunity used the Small Business Technology Transfer (STTR) mechanism and focused on the R42 activity code, which corresponds to an STTR Phase II award.
Was this opportunity intended for Phase I or Phase II STTR projects?
It specifically supported STTR Phase II and STTR Fast-Track applications. A standalone STTR Phase I application was not eligible under this program; Phase I could only be included if submitted as part of a Fast-Track application.
What was the main goal of this funding opportunity?
The central goal was translational: to enable small businesses to run early-stage (exploratory) clinical trials that produce initial human data for a promising neurological intervention or tool. The expectation was that these results would guide subsequent, more definitive trials and help advance product development and commercialization.
What does "exploratory clinical trial" mean in the context of this FOA?
Within the description provided, an exploratory clinical trial refers to early-stage human testing designed to generate initial clinical data rather than to serve as a large, definitive clinical trial. The intent was to support projects ready for human evaluation but still at an early stage of clinical investigation.
Who was eligible to apply?
Eligibility was limited to United States small business concerns (U.S. SBCs), consistent with STTR program rules.
Did the program require cost sharing or matching funds?
No. The opportunity did not require cost sharing or matching funds.
What kinds of projects could be funded under PAR 15-278?
The scope was broad as long as the work aligned with the mission and goals of NINDS and rose to the level of a clinical trial. Projects could include exploratory clinical trials evaluating drugs and biologics, medical devices, diagnostics, and non-pharmacologic interventions such as surgical approaches, behavioral therapies, or rehabilitation strategies.
Were non-drug approaches allowed (for example devices, behavioral therapies, or rehabilitation)?
Yes. The described scope explicitly included medical devices and diagnostics, as well as non-pharmacologic interventions like surgical approaches, behavioral therapies, and rehabilitation strategies, provided the project fit NINDS priorities and involved an exploratory clinical trial.
Did the FOA emphasize basic science or product development?
It emphasized translational, product-oriented development. The focus on "products" indicated an expectation that applicants were developing something with a plausible path to real-world deployment in clinical care or use, rather than pursuing a basic science question alone.
What does "investigator-initiated" mean here?
Based on the description provided, "investigator-initiated" indicates that the clinical trial concepts and study plans were proposed by the applicant (the small business and its partners) rather than being dictated by a pre-specified government study design.
Which NIH institute sponsored or led the scientific focus for this opportunity?
The sponsoring agency was NIH, and the institute responsible for program fit and scientific direction was the National Institute of Neurological Disorders and Stroke (NINDS).
What was the award instrument and activity category?
The award instrument was a grant. The activity category was health.
What CFDA number was associated with this opportunity?
The opportunity was listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was PAR 15-278 posted and when did it close?
The FOA was posted on June 15, 2015. It closed on April 5, 2018, and was archived on May 6, 2018.
Is PAR 15-278 still open for applications?
No. Based on the dates provided, it closed on April 5, 2018 and was archived on May 6, 2018.
Where was the full announcement hosted?
The full announcement was hosted on the NIH Grants Guide website (the NIH grants guide link referenced in the source information).
Who could applicants contact for technical access issues?
NIH Office of Extramural Research (OER) support contacts were listed for technical access issues.
What kinds of applicants was this NOT designed for?
Based on the structure described, it was not aimed at applicants seeking a standalone STTR Phase I award under this particular FOA, and it was not designed for projects remaining at preclinical or concept demonstration stages without justification for moving into an exploratory clinical trial.
Why did the FOA focus on Phase II and Fast-Track rather than Phase I alone?
The described structure reflects the intent to support projects positioned to move efficiently into a Phase II development effort that includes an exploratory clinical trial, rather than funding very early feasibility work in isolation.
What is the practical value of this program for a small business?
In practical terms, it was intended to provide a clear pathway for a U.S. small business to advance a neuroscience-related product into early human testing when the work qualifies as a clinical trial, producing initial human data to guide later trials and commercialization efforts.
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