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.Apply for RFA DA 25 052
- 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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Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-DA-25-052.
Which agency is offering this grant?
This opportunity is offered by the National Institutes of Health (NIH).
What type of grant mechanism is being used?
This opportunity uses the SBIR mechanism under R43/R44. In general, R43 corresponds to Phase I (early-stage R&D), and R44 corresponds to Phase II (follow-on development and commercialization steps if Phase I is successful).
Is this opportunity specifically for small businesses?
Yes. Eligibility is limited to small businesses, consistent with the SBIR (R43/R44) framework.
What is the activity area and CFDA listing for this opportunity?
The opportunity is in the health and education activity area and is listed under CFDA 93.279.
What is the application closing date listed for this opportunity?
The application closing date listed is March 14, 2024.
What is the award ceiling shown for this opportunity?
The award ceiling shown is $295,924.
What is the main goal of this grant opportunity?
The central goal is to accelerate development of practical tools that make decentralized clinical trials (DCTs) feasible and reliable in the substance use disorder (SUD) space.
What does NIH mean by a decentralized clinical trial (DCT) in this context?
In this context, 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.
Why is NIH emphasizing decentralized clinical trials for substance use disorder research?
NIH highlights that DCTs can improve access, retention, and real-world relevance. At the same time, NIH notes that the substance use field has major technology and infrastructure gaps that make DCTs hard to implement at scale, which this funding aims to address.
What kinds of technology gaps is NIH trying to solve with this opportunity?
The notice points to gaps in (1) sensing and measurement technologies that can work outside clinics/labs, (2) wearable or home-use detection devices for substances important in SUD research, and (3) data integration capabilities, including standard software interfaces for transmitting data to study centers.
Does NIH only want brand-new sensors, or can projects focus on validating existing sensors?
Based on the notice, NIH signals interest not only in inventing new sensors, but also in building the evidence base and performance testing needed for physiological sensors to be trusted for rigorous clinical trial endpoints, including additional validation where needed.
What is meant by "better sensing and measurement technology" for use outside a clinic or laboratory?
The opportunity describes a need for sensing and measurement technologies that can operate in participants' homes or local settings and still produce data reliable enough for clinical trial use, including considerations like accuracy, reliability, and usability in real-world remote settings.
What substance detection capabilities does the announcement specifically call out as missing from the market?
The description specifically calls out the absence of market-available wearable or home-use detection devices capable of measuring methadone, buprenorphine, their metabolites, and a broader range of illicit drugs.
Why are methadone, buprenorphine, and their metabolites highlighted?
In the notice, these measurements are tied to clinical trial needs such as adherence monitoring, outcome verification, relapse detection, and safety monitoring in the context of substance use disorder research and treatment evaluation.
Are laboratory-based measurement approaches considered a good fit for decentralized clinical trials?
The notice suggests laboratory-based options are a poor fit for decentralized trial designs because they are not designed for participants to use at home or in the community.
Are the tools expected to be diagnostic or treatment devices?
The announcement emphasizes that many devices under development are not intended for diagnostic or treatment use, and the solicitation is focused on tools to support clinical trials rather than regulated clinical diagnostics or therapeutic devices.
If the tools are research-focused, does NIH still care about real-world usability?
Yes. The notice highlights practical deployment barriers and implies that even research-use tools must be designed for real-world remote use, including user experience, reliability, and integration into trial workflows.
What kinds of software and data integration needs are mentioned?
Data integration is a prominent theme. The opportunity states that most existing devices lack a standard software interface to transmit data directly to a study center, pointing to a need for interoperable data pipelines and standardized interfaces for secure, consistent, efficient data transfer.
Why is having a standard software interface important for decentralized clinical trials?
For DCTs, the value of a home-use test or sensor depends heavily on whether its data can be securely captured, time-stamped, quality-checked, and incorporated into trial databases and monitoring systems. The notice encourages solutions that address both hardware and software/connectivity needs.
Is the opportunity limited to U.S.-based applicants?
Yes. The notice explicitly states that non-U.S. (foreign) organizations are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. The notice states that non-domestic components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed at all under this opportunity?
The notice indicates that foreign components, as defined by the NIH Grants Policy Statement, may be allowed. This typically means certain discrete elements of a project may occur abroad under specific conditions and approvals, even though the applicant organization must be U.S.-based and the project cannot be structured around an ineligible non-domestic component.
What kinds of solutions does NIH appear to be encouraging overall?
Overall, NIH is encouraging small-business solutions that create, adapt, validate, and integrate technologies enabling decentralized SUD clinical trials, with particular attention to remote detection of relevant substances, improved validation and use of physiological sensors, and robust software interfaces for secure data transmission to study centers.
How does this opportunity relate to making SUD trials more scalable and reflective of real-world conditions?
The notice frames the intent as removing practical barriers that prevent DCT approaches from being broadly used in substance use research, thereby supporting trials that are more accessible, scalable, and reflective of real-world conditions.
Does this opportunity allow clinical trials?
Yes. The title indicates "Clinical Trials Optional," meaning clinical trials are optional under this opportunity.
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Applicants who have applied for this opportunity (RFA DA 25 052) also looked into and applied for these:
| Funding Opportunity |
|---|
| Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional) Apply for RFA DA 25 051 Funding Number: RFA DA 25 051 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,972,828 |
| Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed) Apply for RFA AT 24 006 Funding Number: RFA AT 24 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: $850,000 |
| Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes (R01 Clinical Trial Optional) Apply for RFA DA 25 021 Funding Number: RFA DA 25 021 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Short Courses in Social Determinants of Health for Research Education in Nursing Research (R25 Independent Clinical Trial Not Allowed) Apply for RFA NR 24 002 Funding Number: RFA NR 24 002 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional) Apply for RFA DA 25 022 Funding Number: RFA DA 25 022 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Exploratory Grant Award to Promote Workforce Diversity in Basic Cancer Research (R21 Clinical Trial Not Allowed) Apply for PAR 24 039 Funding Number: PAR 24 039 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
| Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional) Apply for RFA DA 25 058 Funding Number: RFA DA 25 058 Agency: National Institutes of Health Category: Education, Health Funding Amount: $2,000,000 |
| Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) Apply for PAR 23 314 Funding Number: PAR 23 314 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
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| Advancing Genomic Medicine Research (R01 Clinical Trial Optional) Apply for RFA HG 23 032 Funding Number: RFA HG 23 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities (UG3/UH3, Clinical Trial Required) Apply for PAR 24 053 Funding Number: PAR 24 053 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advancing Genomic Medicine Research (R21 Clinical Trial Optional) Apply for RFA HG 23 033 Funding Number: RFA HG 23 033 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Rural Community-Centered Drug Misuse Prevention and Harm Reduction Research: Addressing Implementation, Dissemination, and Equity Challenges across the Continuum of Care (R61/R33 Clinical Trial Only) Apply for RFA DA 24 036 Funding Number: RFA DA 24 036 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional) Apply for PAR 24 062 Funding Number: PAR 24 062 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| National Drug Early Warning System Coordinating Center (U01 Clinical Trial Not Allowed) Apply for RFA DA 25 029 Funding Number: RFA DA 25 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Required) Apply for RFA DA 25 027 Funding Number: RFA DA 25 027 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not Allowed) Apply for PAR 23 286 Funding Number: PAR 23 286 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies with Humans Required) Apply for PAR 23 288 Funding Number: PAR 23 288 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Required) Apply for PAR 23 287 Funding Number: PAR 23 287 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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