Duke Early Phase Clinical Research

Duke Early Phase Clinical Research combines clinical, analytical, and operational expertise to accelerate the availability of therapies, diagnostics, and medical devices to humans.

As part of the Duke Clinical Research Institute, the world’s largest academic research organization, the Early Phase team partners with pharmaceutical, biotech, medical device, government agencies, foundations, and academic centers to conduct a broad range of early phase studies. From our state-of-the-art 34-bed research unit to robust analytics, we offer our partners a new path to proof by building on our strength of expertise and experience.

Duke Early Phase Clinical Research has the staff, resources, and expertise to conduct a variety of studies, from proof-of-concept to first-in-human, including:

  • Thought leadership and scientific insight in early phase clinical research
  • Duke practicing physicians who see patients every day
  • Full-service capabilities and customized study design grounded in the reality of clinical care
  • Access to healthy and diverse disease-specific patient populations
  • FDA regulatory oversight and compliance

Learn more about Duke Early Phase Clinical Research's capabilities, staff, and collaborations by clicking on the links below:

  • Volunteer Registry and Available Studies
  • Our Services
  • Specialized Facilities and Technologies
  • Rapid Recruitment
  • Study Design
  • Data Analytics
  • Our Staff
  • Collaborations
  • Publication Highlights
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Volunteer Registry & Available Studies

The role of study volunteers in clinical research is crucial in the advancement of medicine. Without volunteer participation, new ways to prevent, diagnose, and treat diseases cannot be achieved. Duke Early Phase Clinical Research has several active studies currently recruiting volunteers. Click below to learn more about what participation entails, and what studies are currently available. If you are interested in being considered for future research studies you can also join our Research Volunteer Registry.

Learn More

Our Services

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Recruitment Core

Recruitment services are available for all studies conducted in the Duke Early Phase Clinical Research Unit. We have a dedicated recruitment team that develops recruitment action plans and advertising materials for IRB submission, coordinates media efforts, and manages incoming calls for potential participants.

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Laboratory Services

Our processing laboratory is staffed by experienced technicians who can perform specimen collection in addition to point-of-care testing. They expertly handle all facets of specimen management, including a robust chain of custody. Our staff follows study-specific protocols to process, aliquot, and store samples. Laboratory equipment is routinely monitored and maintained. Capability for short-term storage (up to 90 days) or immediate shipment to central laboratories is available.

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24/7 Medical Staff Coverage

The Duke Early Phase Clinical Research Unit is capable of providing 24/7 medical coverage, which includes an on-site respiratory therapist. As a hospital-based unit, we have immediate access to the full complement of emergency-response capabilities of Duke University Hospital, such as code teams, emergency department, and a 900+ bed quaternary care facility.

Our Staff

While at the Duke Early Phase Unit, subjects are cared for by a team of hospital-credentialed nurses, certified nursing assistants, certified medical assistants, medical laboratory technicians, phlebotomists, and nutrition personnel.

Leadership

Jeffrey Guptill, MD, MA, MHS
Director, Duke Early Phase Clinical Research

Donna Hamel, RCP, FAARC, FCCM
Director of Operations, Duke Early Phase Clinical Research
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CTSA Collaborators

CTSA researchers seeking clinical expertise and operational capacity to translate preclinical discoveries, new technologies, or device prototypes to humans can collaborate with Duke Early Phase Clinical Research to conduct a broad range of early phase, proof-of-concept, and first-in-human studies.

Our thought leaders optimize clinical trial design to increase operational efficiencies while maintaining regulatory compliance.

“The Duke Early Phase Clinical Research Unit (DEPRU) is an outstanding resource that made my goal of conducting a phase 1 clinical trial in healthy volunteers possible. Working collaboratively with the University of Kentucky Center for Clinical and Translational Science, DEPRU efficiently performed start-up activities, enrolled subjects according to study timelines, and provided high-quality data.

This collaboration within the CTSA infrastructure at both institutions enabled the timely and extremely capable conduct of the phase 1 trial. I strongly endorse DEPRU to CTSA investigators in need of early phase clinical trial services for the development of therapeutics with the goal of improving the lives of patients.”

 

Linda J. Van Eldik, PhD
Director, Sanders-Brown Center on Aging and Alzheimer's Disease Center
Co-Director, Kentucky Neuroscience Institute
Dr. E. Vernon Smith and Eloise C. Smith Alzheimer's Research Endowed Chair
Professor, Department of Neuroscience
University of Kentucky

Publication Highlights

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus.

In this PK-PD study of a novel B cell depleting therapeutic administered to lupus and rheumatoid arthritis patients, we determined:

  • The drug was well tolerated with pretreatment
  • B cell depletion in this patient population was long-lasting
  • The duration of B cell depletion was greater in patients with rheumatoid arthritis than systemic lupus erythematosus, suggesting higher doses may be required for patients with lupus

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Escalating Dose and Repeated Doses of CN-105 in Healthy Adult Subjects.

In this first-in-human SAD/MAD study of a small peptide beginning clinical development for acute brain injury, we found:

  • No significant safety issues with the compound
  • PK analysis revealed predictable PK properties without significant drug accumulation

Currently a broken link - need study title

In this proof-of-concept cross-over study testing exercise performance in healthy volunteers, we found that:

  • Drugs targeting hypoxia-induced vasoconstriction were well tolerated with no drug interactions
  • Under hypoxic conditions induced in a hyperbaric chamber, submaximal exercise performance improved with combined drug therapy suggesting aminophylline and ambrisentan may improve hypoxia outcomes when supplemental oxygen is not insufficient or unavailable