Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional) | RFA DA 25 052

Opportunity Information: Apply for RFA DA 25 052

The National Institutes of Health (NIH) is offering a small business funding opportunity titled "Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional)" under Funding Opportunity Number RFA-DA-25-052. It is a discretionary grant opportunity in the health and education activity area (CFDA 93.279) and is structured under the SBIR mechanism (R43/R44), which typically supports early-stage research and development (Phase I, R43) and, if successful, follow-on development and commercialization steps (Phase II, R44). The application closing date listed for this opportunity is March 14, 2024, and the award ceiling shown is $295,924. The opportunity is aimed specifically at small businesses.

The central goal of this grant is to accelerate the development of practical tools that make decentralized clinical trials (DCTs) feasible and reliable in the substance use disorder (SUD) space. Decentralized trials shift some or many study activities away from traditional research sites and into participants' homes or local settings, using remote data collection, mobile technologies, and home-based testing. NIH is highlighting that, despite the promise of DCTs to improve access, retention, and real-world relevance, the substance use field still faces major technology and infrastructure gaps that make DCTs difficult to implement at scale.

A major need identified in the notice is better sensing and measurement technology that can operate outside of a clinic or laboratory. The opportunity notes that existing physiological sensors that could support remote monitoring are not widely used in SUD studies and may require additional validation before they can be trusted for rigorous clinical trial endpoints. This signals interest not just in inventing new sensors, but also in building the evidence base and performance testing needed for these tools to be accepted in research settings, especially where accuracy, reliability, and participant usability can make or break a decentralized study.

Another key gap is the lack of wearable or home-use detection devices that can measure substances that matter for SUD research and treatment evaluation. The description specifically calls out the absence of market-available devices capable of measuring methadone, buprenorphine, their metabolites, and a broader range of illicit drugs. In practice, these measurements are often tied to adherence monitoring, outcome verification, relapse detection, and safety monitoring. NIH is underscoring that current options are largely laboratory-based, meaning they are not designed for participants to use at home or in the community, and therefore do not align well with decentralized trial designs.

The announcement also emphasizes that many devices currently under development are not intended for diagnostic or treatment use. That distinction matters because the solicitation is focused on tools to support clinical trials rather than regulated clinical diagnostics or therapeutic devices. In other words, the products of interest may be research-grade tools intended to collect study data, confirm exposure or adherence, and support trial operations, without necessarily being marketed as clinical diagnostic products. At the same time, NIH is calling attention to practical deployment barriers, suggesting that even research-use devices must be designed with real-world remote use in mind, including user experience, reliability, and integration into trial workflows.

Data integration is another prominent theme. The opportunity states that most existing devices lack a standard software interface that would allow them to transmit data directly to a study center. This points to a need for interoperable data pipelines and standardized interfaces so that data collected in a participant's home can be securely, consistently, and efficiently transferred to researchers. For decentralized trials, the value of any sensor or home test is heavily dependent on how easily its data can be captured, time-stamped, quality-checked, and incorporated into trial databases and monitoring systems. NIH is effectively encouraging solutions that address not only the hardware side (wearables, home-use tests) but also the software and connectivity side (interfaces, data transmission, and integration with study operations).

Eligibility is limited to small businesses, consistent with the R43/R44 SBIR framework. The notice explicitly states that non-U.S. (foreign) organizations are not eligible to apply, and that non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement may be allowed, which typically means certain discrete elements of the project may occur abroad under specific conditions and approvals, even though the applicant organization itself must be U.S.-based and the project cannot be structured around an ineligible non-domestic component.

Overall, this opportunity is geared toward small businesses that can create, adapt, validate, and integrate technologies enabling decentralized SUD clinical trials, with particular attention to remote detection of relevant substances, improved use and validation of physiological sensors, and robust software interfaces for secure data transmission to study centers. The intent is to remove practical barriers that currently prevent DCT approaches from being broadly used in substance use research, improving the ability to run trials that are more accessible, scalable, and reflective of real-world conditions.

• 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 (R43/R44 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 $295,924.00 in funding.
• Eligible applicants include: Small businesses.

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