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NIH: National Institute of Diabetes and Digestive and Kidney Diseases NIH: National Institute of Diabetes and Digestive and Kidney Diseases 75 years: 1950-2025 75 years: 1950-2025
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  5. Clinical Development

Translational Research: Clinical Development

Clinical evaluation of novel pre-therapeutics involves a highly regulated process by which the agent is carefully tested in clinical populations. The precise design of these studies varies by the nature of the agent, and in the case of repurposed compounds or naturally occurring biologics may involve existing human safety data. Clinical evaluation of compounds is a continuing process involving larger clinical trials through post-marketing monitoring.

Starting Points
  1. Disease
    Biology
  2. Unvalidated
    Target
    Target ID
    Putative
    Targets
  3. Nominated
    Target
    Assay Development
    Screenable
    Assays
  4. Target Assay
    Screening
    Hits and
    Starting Points
  5. Hit
    Hit to Lead
    Lead Series
  6. Lead
    Compound
    Lead
    Optimization
    Potential
    Therapeutic
    Leads
  7. Clinical
    Candidate
    Clinical
    Development
    Clinical Proof
    of Concept
Outcomes and Resources

NIH Funding Opportunities

  • PA-20-185, NIH Research Project Grant
  • RFA-NS-24-019, HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
  • Potential opportunities include ancillary studies to ongoing clinical studies, exploratory/developmental grants, and investigator-initiated multi-center clinical studies.

Related Resources

Contacts

For more information on NIDDK funding opportunities to support clinical development and testing of new therapeutics, please visit the NIDDK Human Subjects Research page.

Last Reviewed October 2023