Early Phase Study Design

Early Phase Study Design

Duke Early Phase Clinical Research has the staff and resources to conduct a variety of studies including healthy volunteer, proof-of-concept, and patient studies. We have particular expertise in hybrid studies were healthy volunteers and patients are enrolled in the same protocol and in combined protocols were multiple study designs (e.g. SAD, MAD) are incorporated into a single protocol.

We leverage the unique capabilities of an academic medical center, adaptive design methodologies, and access to specialized services and populations (e.g. elderly) to conduct these studies.

Standard Studies

  • Phase 1
  • Healthy volunteers
  • First-in-human
  • Escalating dose (e.g. SAD/MAD)
  • Drug-drug and Drug-food interactions
  • Bioavailability/bioequivalence

Specialized Studies

  • Proof-of-concept (first in patient)
  • Hybrid (healthy volunteers and patients)
  • Special populations (e.g. older adults, patients, children)
  • Combined protocols (multi-part including SAD, MAD, etc)
  • Device/technology validation
  • Long-term confinement
  • Phase 0
  • Invasive procedures/monitoring
  • Innovative PD endpoints
  • Imaging
  • Endotoxin
  • Bionutritional
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