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Laboratories to Optimize Digital Health (R01 Clinical Trial Required)

US · US National Institutes of Health (NIH) grant open #PAR-25-136
Response due Jan 07, 2028 · 00:00 UTC

Summary

This is a National Institutes of Health (NIH) funding opportunity announcement (FOA) under the R01 mechanism requiring a clinical trial. It invites research proposals focused on optimizing digital health technologies and interventions through laboratory-based and/or clinical trial methodologies. The opportunity is a broad, standing announcement open for multiple years (2024–2028), suggesting a programmatic priority at NIH to fund iterative, rigorous studies that improve the efficacy and implementation of digital health tools. Applicants must include a clinical trial component in their proposed research.

What they want

Technical requirements
  • Clinical trial is required as part of the proposed research design
  • Must conform to NIH R01 grant application requirements and format
  • Research must focus on optimizing digital health interventions or technologies
Key personnel
  • Principal Investigator (PI) with relevant expertise in digital health or clinical research

How they evaluate

  • Scientific and technical merit (reviewed by NIH study section)
  • Significance and innovation of proposed digital health research
  • Approach rigor and feasibility of clinical trial design
  • Investigators' qualifications and team expertise
  • Environment and available resources
Submission: Electronic submission via Grants.gov and NIH eRA Commons

Eligibility & certifications

SAM.gov registration (for organizational applicants)NIH eRA Commons registrationCompliance with NIH human subjects research requirementsIRB approval required for clinical trial component

Risks & flags

  • No dollar value or budget cap specified — difficult to assess award size competitiveness
  • Multi-year open window (2024–2028) with rolling submissions typical of NIH PARs — not wired for a single awardee but highly competitive
  • Clinical trial requirement narrows eligible applicant pool to institutions with trial infrastructure

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Laboratories to Optimize Digital Health (R…
Due Jan 07
Onboard