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NIH
Posted

PA-24-193

NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)

Summary

AI-generated

NIH Pathway to Independence Award (K99/R00 – Independent Clinical Trial Required)

Research Focus & Contribution

This award supports postdoctoral researchers transitioning to independent, tenure-track faculty positions while leading their own clinical trials. The program targets physician-scientists and researchers with research/clinical doctorates (MD, DO, DDS/DMD, DVM/VMD, or research doctoral degrees for nurses) who are ready to establish competitive, independent research careers. Applicants must propose to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or an ancillary study to an existing trial. The clinical trial definition encompasses prospective assignment of human subjects to interventions (including placebo or control) to evaluate health-related biomedical or behavioral outcomes. Supported trials include safety and efficacy studies, mechanistic exploratory studies in healthy or diseased populations, and biomarker studies examining physiological function, target engagement, or treatment response. The award aims to generate evidence that will help awardees launch robust, independent research programs competitive for subsequent NIH funding.

At a Glance

  • Who can apply: Postdoctoral researchers with no more than 4 years of postdoctoral experience; must be in mentored positions at time of application; physician-scientists with MD, DO, DDS/DMD, DVM/VMD, or research doctorates (nurses) who devote majority time to biomedical research.

  • Funding & project length: Up to 5 years total: K99 phase (up to 2 years mentored support) + R00 phase (up to 3 years independent support, contingent on faculty position).

  • Award mechanism: K99/R00 Career Transition Award/Research Transition Award across 16 NIH Institutes and Centers (NHLBI, NHGRI, NIA, NIAAA, NIAMS, NIBIB, NICHD, NIDCD, NIDDK, NIDA, NIEHS, NIMH, NINDS, NINR, NIMHD, NLM, NCCIH).

  • Key dates: Application due dates on June 12, 2024 and subsequent standard NIH cycles through February 12, 2027; earliest start date April 2025 onward; expires May 8, 2027.

  • Best fit for: Clinician-scientists and physician-scientists planning independent clinical trials in cardiovascular, genomic, aging, neurological, metabolic, mental health, or other disease-focused research; requires compelling 1–2 year mentored research plan before faculty transition.

Key Facts

Deadline

Fri, May 7, 2027

Posted

Wed, April 24, 2024

Max Duration

5 years

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93.840
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93.242
93.310
93.847
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Grants.gov
Agency

Keywords

clinical trial design
postdoctoral research training
career development
physician-scientists
biomedical research
mentored research
translational research
biomarker studies
research independence
independent research
clinical trial feasibility studies
tenure-track faculty transition
human subjects research
mechanistic exploratory studies

Research Areas

MeSH
DiseasesC
InfectionsC01NeoplasmsC04Nervous System DiseasesC10Cardiovascular DiseasesC14Nutritional & Metabolic DiseasesC18Endocrine System DiseasesC19Immune System DiseasesC20
Chemicals & DrugsD
Hormones & AntagonistsD06Pharmaceutical PreparationsD26
Analytical/Diagnostic/Therapeutic TechniquesE
DiagnosisE01TherapeuticsE02Surgical ProceduresE04Investigative TechniquesE05
Psychiatry & PsychologyF
Behavior MechanismsF01
Phenomena & ProcessesG
MetabolismG03Genetic PhenomenaG05Immune System PhenomenaG12
Disciplines & OccupationsH
Health OccupationsH02
Anthropology/Education/SociologyI
EducationI02
Health CareN
Health Care ServicesN02Health Care EconomicsN03Health Services AdministrationN04Health Care Quality & EvaluationN05
ANZSRC FoR
Biomedical & Clinical Sciences32
Clinical Sciences3202Immunology3204Neurosciences3209Pharmacology & Pharmaceutical Sciences3214
Education39
Specialist Studies in Education3904
Engineering40
Biomedical Engineering4003
Health Sciences42
Epidemiology4202Health Services & Systems4203Public Health4206
Mathematical Sciences49
Statistics4905

Gotchas (4)

Hard Block
eligibilityeligibility mechanism or sponsor

NCI discontinued participation in PA-24-193 as of January 15, 2025. Applicants whose home IC is NCI cannot apply to this NOFO and must identify an alternative mechanism.

AI

99%

Source Text

January 15, 2025 - Notice of the Discontinuation of NCI's Participation in PA-24-193, PA-24-194 & PA-24-195 NIH Pathway to Independence Award (Parent K99/R00). See Notice NOT-CA-25-021.

Hard Block
planningprogram scope topic

This K99/R00 award REQUIRES an independent clinical trial as the lead investigator—not optional. Applicants planning observational studies, non-clinical research, or clinical trials led by another inv

AI

95%

Source Text

This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Candidates not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PA-24-194).

Hard Block
eligibilityeligibility pi career stage

Candidates must have no more than 4 years of postdoctoral research experience at the time of initial or resubmission application. This is a strict eligibility gate that is easy to miscalculate if post

AI

98%

Source Text

Candidates must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application.

Soft Block
discoverymeta ambiguity

R00 awards are contingent on satisfactory K99 progress AND acceptance of an independent tenure-track (or equivalent) faculty position by the end of the K99 period. Exceptions are noted as 'limited,' c

AI

85%

Source Text

The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end

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