Duke Early Phase Clinical Research

Duke Early Phase Clinical Research (Early Phase) is a thirty bed state-of-the-art hospital-based early phase research unit that allows Duke investigators and other investigators to conduct proof-of-concept research.  

Early Phase has the capability to provide services in both an inpatient and an outpatient setting. The unit has 10 hospital-grade beds to service the needs of research subjects who require specialized hospital care during the course of their study visit. The remaining 20 beds are classified as confinement beds. These beds are designed to house subjects who do not require medical standard of care procedures during their study stay. Additionally, Early Phase has six well equipped examination rooms, a metabolic kitchen, a processing laboratory, and wireless internet access.

In addition to early-stage investigator-initiated studies and NIH-funded research, Duke researchers also work with pharmaceutical, biotechnology, and medical device companies to generate data. Early Phase provides the clinical research infrastructure to support investigators in the design, initiation, and conduct and reporting of interdisciplinary and collaborative clinical and translational research.

Operationally, Early Phase is part of the Duke Clinical Research Institute (DCRI). 

At a glance:

  • 34-bed unit, one of the largest academic early phase units in the country
  • 50+ personnel experienced in early phase clinical research
  • Data analytics/reporting (including PK/PD modeling) that meets FDA reporting standards 
  • Large healthy and patient volunteer registry 

Early Phase services include:

  • Research Participant Recruitment Core: Early Phase has a dedicated recruitment team that develops recruitment action plans and materials for IRB submission, coordinates media efforts, and manages incoming calls for potential participants.
  • Laboratory-Specimen Collection, Processing, and Storage: Early Phase can perform specimen collection as well as point of care testing. Samples are promptly processed, split and frozen as required. 
  • Medical Staff Coverage: Early Phase can provide 24/7 medical coverage with physicians and/or nurse practitioners. As a hospital based unit, it has immediate access to emergency response capabilities of Duke University Hospital.
  • Nursing: Early Phase research nursing staff are skilled in advanced assessment, phlebotomy, IV therapy, ECG, and chemotherapy administration.
  • Nutrition: Early Phase includes a nutrition research team capable of providing specialized diets and nutrition requirements for studies.
  • Pharmacy: Pharmacists work in collaboration with Duke Hospital and Morris Cancer Center pharmacies to  provide comprehensive management of all facets of study agent handling including ordering, IVRS/IWRS/Randomization, receipt and secure climate-controlled storage, preparation, accountability and records retention, returns/destruction, staff education and training, and a robust quality management system.
  • Project Management and Research Coordination: Project management staff includes project leaders, study coordinators, regulatory coordinators, and clinical trial assistants

 

Work with Early Phase:

Contact Juan Martinez at jaun.martinez@duke.edu or (919) 384-6418 with details about your research question and needs. You will receive a response within 24 hours.