Opportunity Information: Apply for RFA DA 25 051
Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional), funding opportunity number RFA-DA-25-051, is a National Institutes of Health (NIH) small business grant opportunity designed to accelerate practical tools that make decentralized clinical trials (DCTs) workable in the substance use disorder (SUD) space. The central idea is that SUD research has not fully benefited from DCT models because the field lacks fit-for-purpose, validated, and interoperable ways to collect objective data outside of traditional clinical sites. This opportunity supports small companies that can close those gaps by developing technologies that enable remote participation, remote monitoring, and reliable data transmission to study teams, with clinical trials being optional under the announcement.
A major problem the solicitation highlights is that, while many physiological sensors exist, they are rarely adopted in SUD trials and often require additional validation to be credible and useful in this context. In addition, the announcement calls out a particularly significant technology gap: there are currently no wearable or home-use detection devices on the market that can measure key substances relevant to treatment and illicit use. Examples explicitly mentioned include methadone, buprenorphine, their metabolites, and a broader spectrum of illicit drugs. In practice, this means that many trials still rely heavily on site-based specimen collection or lab-based methods that create barriers for participants, slow down data collection, and limit how “decentralized” a trial can realistically be.
The opportunity also points to practical deployment issues that keep emerging devices from being used in real-world trials. Many devices in development are built primarily for laboratory environments rather than home or field use, and several are not intended for diagnostic or treatment purposes. On top of that, a key operational hurdle is interoperability: most devices do not provide a standard software interface that allows secure, consistent transmission of data back to the study center. NIH is signaling that solutions need to be more than clever prototypes; they need to function within a clinical trial workflow, including routine data capture, secure transfer, and integration with study data systems. For DCTs, that typically implies attention to usability, reliability, participant burden, data quality, and the ability to support monitoring and oversight remotely.
From a funding and administrative standpoint, this is an NIH discretionary grant using the SBIR/STTR-style R41/R42 mechanism. Eligibility is limited to small businesses. The listed Assistance Listing (CFDA) number is 93.279, and the awarding agency is NIH. The original closing date shown is March 14, 2024. The opportunity lists an award ceiling of $1,972,828, indicating the maximum anticipated award amount per project under the solicitation. The record provided does not specify the exact number of expected awards, but the presence of a ceiling helps frame the potential scale of funded development.
The eligibility rules include notable restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some cases, which typically means that limited, well-justified foreign collaboration or work may be permissible if it fits NIH policy and is appropriately documented. Overall, the opportunity is aimed at U.S.-based small businesses that can deliver enabling tools for decentralized SUD trials, especially technologies that can objectively measure relevant substances or physiological signals in home or wearable formats and that can move data to study centers through standardized, trial-ready software interfaces.Apply for RFA DA 25 051
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2023-10-25.
- Applicants must submit their applications by 2024-03-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,972,828.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the funding opportunity called?
The opportunity is titled Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional).
What is the funding opportunity number?
The funding opportunity number is RFA-DA-25-051.
Which agency is offering this opportunity?
The awarding agency is the National Institutes of Health (NIH).
What type of grant mechanism is this?
This is an NIH small business opportunity using the SBIR/STTR-style R41/R42 mechanism.
Who is eligible to apply?
Eligibility is limited to small businesses.
Are foreign organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
Can a U.S. small business include work performed outside the United States?
The information provided states that non-domestic components of U.S. organizations are not eligible. However, it also notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some cases, typically when the foreign involvement is limited, well-justified, and appropriately documented under NIH policy.
What is the main goal of this funding opportunity?
The goal is to accelerate practical tools that make decentralized clinical trials (DCTs) workable in the substance use disorder (SUD) space, especially by enabling objective data collection outside traditional clinical sites.
What problem is NIH trying to solve with this solicitation?
The solicitation highlights that SUD research has not fully benefited from decentralized clinical trial models because the field lacks fit-for-purpose, validated, and interoperable ways to collect objective data remotely. As a result, many studies still depend on site-based specimen collection or lab methods that add burden, slow data capture, and reduce how decentralized a trial can be.
What kinds of tools or technologies is NIH looking to fund?
The opportunity supports technologies that enable remote participation, remote monitoring, and reliable data transmission to study teams. The emphasis is on solutions that work within real clinical trial workflows rather than remaining as lab-only prototypes.
Are clinical trials required under this opportunity?
No. The opportunity is labeled Clinical Trials Optional, meaning clinical trials are not required under the announcement based on the information provided.
Why are existing physiological sensors not widely used in SUD trials?
The solicitation notes that many physiological sensors exist but are rarely adopted in SUD trials and often require additional validation to be credible and useful in the SUD clinical trial context.
What major technology gap does the announcement specifically call out?
A key gap is that there are currently no wearable or home-use detection devices on the market that can measure key substances relevant to treatment and illicit use.
Which substances are explicitly mentioned as examples of what devices should be able to measure?
Examples explicitly mentioned include methadone, buprenorphine, and their metabolites, as well as a broader spectrum of illicit drugs.
What practical deployment issues does NIH highlight for emerging devices?
The opportunity points to several issues that prevent real-world use in trials, including devices being built primarily for laboratory environments rather than home or field use, and the fact that some devices are not intended for diagnostic or treatment purposes.
What does NIH mean by interoperability in this context?
Interoperability refers to devices providing a standard software interface that enables secure, consistent transmission of data back to the study center and supports integration with study data systems.
What characteristics should a “trial-ready” solution include according to the description?
NIH is signaling that solutions should function inside a clinical trial workflow, including routine data capture, secure transfer, and integration with study data systems. For decentralized trials, this also implies attention to usability, reliability, participant burden, data quality, and the ability to support remote monitoring and oversight.
What is the Assistance Listing (CFDA) number for this opportunity?
The listed Assistance Listing (CFDA) number is 93.279.
What is the closing date shown for this opportunity?
The original closing date shown is March 14, 2024.
What is the maximum anticipated award amount?
The opportunity lists an award ceiling of $1,972,828, which indicates the maximum anticipated award amount per project under the solicitation.
How many awards does NIH expect to make?
The information provided does not specify the exact number of expected awards.
What does the award ceiling tell applicants?
While it does not guarantee a specific award size, the stated ceiling helps frame the potential scale of funded development under this solicitation.
Why is decentralized trial enablement especially important for SUD studies?
Based on the description, decentralized approaches can be limited in SUD research because objective measurements often still require clinic visits or lab processing. Tools that support remote measurement and secure data transfer can reduce barriers for participants, improve timeliness of data collection, and make DCT designs more realistic in this field.
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