← Back to contracts

National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

US · MD · Bethesda National Cancer Institute (NCI) / National Institutes of Health (NIH) grant open #PAR-25-081
Response due Jan 07, 2027 · 00:00 UTC

Summary

The National Cancer Institute (NCI), a component of the National Institutes of Health (NIH), is soliciting investigator-initiated early phase clinical trials focused on cancer treatment and diagnosis. This is a Program Announcement with special receipt, referral, and/or review considerations (PAR) requiring an R01 grant mechanism with a mandatory clinical trial component. The opportunity is open to researchers proposing novel early-phase (Phase I/II) clinical studies in oncology. The posting window spans over two years, suggesting multiple submission cycles are anticipated.

What they want

Applicants must propose and conduct investigator-initiated early phase clinical trials (Phase I and/or Phase II) directed at cancer treatment and/or diagnosis. The R01 mechanism requires a structured research plan including clinical trial design, endpoints, patient population, and safety monitoring. A clinical trial is required as part of the application; basic science or observational studies alone are not eligible. Research must align with NCI's mission to advance cancer science.
Technical requirements
  • Clinical trial required as part of the application (R01 Clinical Trial Required)
  • Early phase trial design (Phase I and/or Phase II)
  • Focus on cancer treatment and/or diagnosis
  • Must follow NIH R01 grant application format and requirements

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • No dollar value or award ceiling stated — budget expectations unclear
  • Multi-year open window (Nov 2024–Jan 2027) suggests rolling submissions across standard NIH due date cycles rather than a single competitive deadline
  • Mandatory clinical trial requirement may exclude a large share of basic-science research groups, narrowing the applicant pool

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
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.

National Cancer Institute's Investigator-I…
Due Jan 07
Onboard ↗