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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