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.

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Our full service early phase clinical research unit and seamlessly integrated analytical group brings a unique academic approach to clinical validation and innovation.

Your Path to Proof

We are driven by innovation and public health impact. With 50+ experienced personnel in early phase clinical research, a state-of-the-art research unit, and robust data analytics, we offer our partners a different approach to early phase research, including:

  • Thought leadership and scientific insight in early phase clinical research that leads to innovation
  • Full-service capabilities and customized study design grounded in the reality of clinical care
  • Access to healthy and diverse disease-specific patient populations

Our Capabilities

Duke Early Phase Clinical Research has the staff and resources to conduct a variety of studies, from proof-of-concept to first-in-human. We leverage the unique capabilities of an academic medical center, adaptive design methodologies, and access to specialized services to conduct healthy volunteer and POC studies. Explore our capabilities:

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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.

Here's what you need to know about participation.

Volunteer Registry

If you are interested in being contacted for future research studies when it appears that you may be eligible based on the information you provide us, join our Research Volunteer Registry.

Have Questions?

Our recruitment staff is available Monday-Friday to answer your questions. If you call outside these hours, leave a message, and your call will be returned.

  • Interested in a study for healthy volunteers, call 919-613-6244
  • Interested in a study for a specific medical condition, call 919-613-6246

Need to find us? Get driving directions here.

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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.

Margaret Stewart
Study Manager

Lynn Jordan
Senior Project Manager
Clinical Laboratory Manager

Lou Cappoli
Business and Recruitment Manager

Debra Freeman
Nurse Manager

Our Leadership

Michael Cohen-Wolkowiez

Michael Cohen-Wolkowiez, MD, PhD

Faculty Director, Duke Early Phase Clinical Research

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

Donna Hamel, RCP, FAARC, FCCM
Director of Operations, Duke Early Phase Clinical Research
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Selected Study Publications

Study Publication Link. 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

Study Publication Link. 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

Study Publication Link. 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

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