Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01 Clinical Trial Optional) | PA 18 056

Frequently Asked Questions (FAQs)

What is the title of this funding opportunity?

The opportunity is titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01 Clinical Trial Optional)."

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is PA 18-056.

Which agency is offering this grant opportunity?

This is a National Institutes of Health (NIH) discretionary grant program.

What grant mechanism does this opportunity use?

It uses the NIH Research Project Grant (R01) mechanism.

What is the overall purpose of the FOA?

The purpose is to strengthen the development and clinical evaluation pipeline for medications targeting Substance Use Disorders (SUDs) by supporting the clinical development of minimally invasive or non-invasive bioassays that can be used in outpatient clinical trial settings.

What kinds of research projects does this FOA support?

The FOA encourages projects that create and clinically develop minimally invasive or non-invasive bioassays intended to support outpatient pharmacotherapy trials for SUDs, including improving measurement of drug exposure, treatment adherence, substance use, and related biological signals in real-world outpatient conditions.

Why is the FOA focused on outpatient SUD clinical trials?

Outpatient SUD trials can face missed visits, unreliable self-report, difficulty confirming recent substance use, and logistical burdens associated with repeated collection of conventional biospecimens (such as venous blood draws). The FOA aims to reduce these burdens and improve retention and data quality.

What does "minimally invasive" or "non-invasive" mean in the context of this FOA?

In this context, it refers to low-burden biological measurements that are more feasible in outpatient environments and may reduce or avoid procedures like repeated venous blood draws. The provided description suggests approaches that could be collected at home or in community clinics.

Does the FOA list specific technologies or specimen types that must be used?

No. The excerpt does not list required technologies or specific specimen types. It describes the general goal of developing minimally invasive or non-invasive bioassays suitable for outpatient clinical trial use.

What kinds of approaches are implied by the FOA description?

While not specified as requirements, the description implies low-burden or non-invasive approaches that could work in outpatient settings, potentially including at-home or community-based collection. Examples commonly associated with "non-invasive methods" in this area include saliva, breath, sweat, urine alternatives, hair, interstitial fluid sampling approaches, wearable or patch-based sampling, or other techniques that reduce the need for phlebotomy or intensive clinic-based procedures.

Is this FOA only about inventing a new assay in the lab?

No. The emphasis is on clinical development and demonstrating that a bioassay can reliably support outpatient pharmacotherapy trials for SUDs in a usable, real-world workflow, not only on laboratory invention.

What outcomes or improvements is NIH trying to achieve through this FOA?

The FOA is intended to make outpatient SUD trials more feasible and scientifically rigorous by improving how researchers measure drug exposure, adherence, substance use, and biological signals, especially when frequent clinic visits and traditional specimen collection are burdensome.

What does "Clinical Trial Optional" mean for applicants?

"Clinical Trial Optional" means applicants may include a clinical trial component if it is appropriate for the bioassay development and validation work, but a clinical trial is not strictly required for every application.

How might a clinical trial component fit within a project under this FOA?

Based on the description, a clinical trial component could be used to clinically validate a minimally invasive bioassay or to integrate and evaluate it within an outpatient therapeutic trial workflow, if that is appropriate for demonstrating feasibility and reliability.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.279.

What category is this grant listed under?

The grant is categorized under Education and Health.

What is the award ceiling for this opportunity?

The listed award ceiling is $500,000.

Is the $500,000 ceiling per year or total project funding?

The provided text does not clarify whether the $500,000 ceiling is per year or total. It notes that award ceilings are often interpreted as a per-year direct cost cap only if explicitly stated in the FOA, and that this excerpt does not specify that detail.

How many awards will NIH make under this FOA?

The expected number of awards is not provided in the excerpt. This often means awards depend on application volume, merit, and available appropriations.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are community-based or faith-based organizations eligible?

Yes. The FOA explicitly highlights faith-based or community-based organizations as eligible applicants.

Are minority-serving institutions specifically encouraged or included as eligible?

Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are U.S. territories or possessions eligible to apply?

Yes. The FOA highlights U.S. territories or possessions as eligible applicants.

Are non-U.S. entities (foreign organizations) eligible to apply?

Yes. The FOA highlights non-U.S. entities (foreign organizations) as eligible applicants.

Are federal agencies eligible to apply?

Yes. The FOA highlights eligible federal agencies as eligible applicants.

When was this FOA created, and what is the listed closing date?

Administrative details indicate the FOA was created on 2017-11-02 and lists an original closing date of 2018-09-07.

Is this FOA from a past funding cycle?

Yes. The listed dates indicate it originates from a past cycle. The description notes that similar FOAs are sometimes reissued or continued under updated numbers, but that is not confirmed in the excerpt.

What types of challenges in outpatient SUD trials is this FOA trying to address?

The FOA targets practical challenges such as missed visits, unreliable self-report, difficulties confirming recent substance use, and the logistical complexity and participant burden of repeated conventional biospecimen collection (for example, venous blood draws).

What kinds of measurements are bioassays expected to support in these trials?

The FOA emphasizes improving measurement of drug exposure, treatment adherence, substance use, and related biological signals during outpatient pharmacotherapy trials.

What would a strong application be expected to include, based on the excerpt?

The excerpt suggests a strong application would: (1) explain a clear clinical need in outpatient SUD pharmacotherapy trials; (2) propose a minimally invasive bioassay that addresses that need; and (3) present a credible plan for development, analytical validation, and clinical validation in the intended outpatient setting.

What would reviewers likely look for in evaluating proposed bioassays (based on the excerpt)?

The excerpt indicates reviewers would typically look for evidence that the assay performs reliably under real outpatient conditions, is acceptable and feasible for participants and study staff, and meaningfully improves the ability of clinical trials to evaluate SUD therapeutics by producing more accurate, timely, or interpretable biological data than existing approaches.

Does this FOA prioritize real-world feasibility and workflow integration?

Yes. The description emphasizes that the bioassay should be usable in outpatient trial settings and should improve feasibility and scientific rigor under real-world or near-real-world conditions (for example, participants living at home with less intensive monitoring than inpatient research).