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.

Got 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
Research Practice Manager

Lynn Jordan
Sr. Research Program Leader

Lou Cappoli
Manager, Clinical Trials Operations

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 Publications

  • Cohen S, Clowse M, Pardo P, Bhattacharya I, Menon S, Gourley I, Diehl A. 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, Clinical Therapeutics, Volume 38, Issue 6, June 2016, Pages 1417-1434.e2. doi: 10.1016/j.clinthera.2016.03.028. PMID: 27112532
  • Guptill JT, Raja S, Ramey S, Boakye-Agyeman F, Noveck R, Tu T-M, Laskowitz D. Phase I, 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. J Clinical Pharmacology, [Epub ahead of print], 2016. doi: 10.1002/jcph.853 PMID: 27990643
  • Schroeder T, Piantadosi CA, Natoli MJ, Autmizguine J, Cohen-Wolkowiez M, Hamilton KL, Bell C, Klawitter J, Christians U, Irwin DC, Noveck RJ. Treating hypoxemia without supplemental oxygen: Combined aminophylline and ambrisentan are safe and improve hypoxic exercise performance. Clinical Pharmacology & Therapeutics, in press, 2017.

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