Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21 Clinical Trial Optional) | PA 18 075

Opportunity Information: Apply for PA 18 075

The National Institutes of Health (NIH) announced a discretionary grant funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21 Clinical Trial Optional)," published as Funding Opportunity Number PA 18 075. The mechanism is an NIH Research Project Grant (R21), which is commonly used to support early-stage, exploratory, or proof-of-concept research that can open up new lines of investigation or de-risk a newer clinical or technological approach. The FOA sits within the Education and Health activity category and is associated with CFDA number 93.279. The opportunity was created on November 2, 2017, with an original closing date of September 7, 2018.

The core purpose of the FOA is to stimulate the development and clinical advancement of non-invasive or minimally invasive bioassays that can be used in outpatient clinical trials of pharmacotherapies for substance use disorders (SUDs). In practical terms, the program is aiming to make it easier, more scalable, and more patient-friendly to measure drug exposure, treatment response, substance use or relapse, adherence, or related biological signals during trials that take place largely outside the hospital or inpatient setting. By focusing on outpatient trials, the announcement highlights a real-world need: SUD treatment studies often depend on frequent monitoring, but standard lab-based sampling (for example, repeated venipuncture or in-clinic specimen collection) can be burdensome, expensive, and a barrier to retention, especially for participants who face transportation, work, or childcare constraints. Minimally invasive bioassays, such as approaches that rely on easier sample collection or less intrusive sensing, can improve participant engagement and data quality while reducing trial complexity and cost.

The FOA is also labeled "Clinical Trial Optional," meaning applicants may propose projects that include a clinical trial component if it is justified by the aims, but they are not required to run a clinical trial to be responsive. This flexibility allows proposals ranging from method development and validation studies in clinical or quasi-clinical settings through to pilot clinical evaluations embedded within therapeutic development pipelines, as long as the overall goal is to create or refine bioassay tools that directly support outpatient pharmacotherapy trials for SUDs.

Eligibility is broad and is designed to encourage participation across many sectors and institution types. Eligible applicants include a wide range of government entities (state, county, city or township governments, and special district governments), education institutions (independent school districts; public and state-controlled institutions of higher education; and private institutions of higher education), and tribal organizations (federally recognized Native American tribal governments as well as tribal organizations other than federally recognized governments). The FOA also welcomes public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories), for-profit organizations (other than small businesses), small businesses, and other applicants as allowed by NIH policy. In addition, the announcement explicitly calls out a set of other eligible applicant categories to broaden participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible agencies of the federal government, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility aligns with the public health nature of SUD research and the practical reality that innovation in bioassays can come from academic labs, clinical research networks, community organizations, technology developers, and global collaborators.

Several administrative fields in the source listing are not populated, including the award ceiling and expected number of awards, so the public summary does not provide a hard cap per award or a projected award count. As a result, applicants would typically look to the full FOA text and NIH R21 budget guidance for the most accurate expectations about project scale, allowed costs, and project period. Overall, the opportunity is designed to accelerate the creation and clinical readiness of patient-friendly biological measurement tools that can make outpatient SUD pharmacotherapy trials more feasible, more reliable, and more reflective of real-world treatment settings.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21 Clinical Trial 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 2017-11-02.
• Applicants must submit their applications by 2018-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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