About DEPRU
As part of the Duke Office of Clinical Research, 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.
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
Learn more about the DOCR Service Centers
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.
Available studies can be found under the Volunteering tab at the top of this page.
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.
Our Services
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:
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.
Laboratory Specimen Collection, Processing, and Storage
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.
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.
Nursing
Our research nursing staff is composed of fully credentialed Duke Hospital registered nurses, certified/registered medical assistants, and health unit coordinators. Nursing team members are skilled in advanced assessm
ent, phlebotomy, IV therapy, ECG, and chemotherapy administration and are BLS-, ACLS-, and PALS-certified.
Metabolic Kitchen to Meet Study Demands
Our nutrition team works within a research kitchen and is capable of providing specialized diets and services that include controlled-nutrient and metabolic diets.
Pharmacy
We work in close collaboration with the Duke University Hospital Department of Pharmacy Investigational Drug Services to provide comprehensive management of all facets of study agents, 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
The unit provides an experienced staff of project leaders, study coordinators, regulatory coordinators, and clinical trial assistants who are dedicated to helping investigators accomplish their research goals while maintaining compliance with all applicable regulations and standards.
Volunteer Recruitment
Tools that permit us to query the Duke medical record system and a proprietary research volunteer registry give us the ability to rapidly identify suitable study candidates after the appropriate approvals have been obtained.
Case Studies
We are able to initiate the regulatory process in parallel with contracting negotiations to expedite the time between contract signature and a study’s institutional approval.
Our Facilities
Duke Early Phase Clinical Research has the capability to provide services in both inpatient and outpatient settings. The Early Phase Unit has 28 hospital-graded beds to service the needs of research subjects who require specialized hospital care during the course of their study visit.
Facilities
Our hospital-based beds maximize subject safety and provide on-site access to a full array of specialized procedures and technologies. The remaining 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, the Early Phase Unit has six well-equipped examination rooms, two processing laboratories, and a metabolic kitchen.
Amenities
Subjects have access to wireless Internet throughout the clinic and televisions in their shared rooms. If protocols permit, subjects can also access our multipurpose room, a subject reading room, laundry facility, and a large, comfortable lounge equipped with games, computers, and television.
Security
We have immediate, around-the-clock access to an on-site, full-scale emergency response team and MD coverage. The Early Phase Unit also provides extensive security measures for your staff and subjects, including cameras, alarms, locked elevators, and Duke Security personnel on-site 24 hours a day.
Specialized Technology
We offer access to a variety of core laboratories equipped with cutting-edge technologies to better understand disease and predict drug response.
ECG management
Real-time ECG collection, monitoring, and interpretation. We use Mortara® wireless 12-lead ECG digital telemetry, allowing for easy transfer of data.
Immune system effects
Examination of the subtle effects of medical interventions on the human immune system. This includes immunogenicity, immunocompetence, immune reconstitution, and immunotoxicity. Our partnering laboratory uses immunoassays that are robust and reproducible, highly sensitive and specific, and fully validated and standardized to support multicenter studies.
"Omics" equipment
Specialized “omics” equipment and expertise. The omics facilities we can access perform high-throughput assays and data analysis for genome sequencing, genotyping, gene expression, proteomics, and metabolomics to study the effects of medical interventions on human physiology and disease states.
Product management
Receipt of cellular products (frozen, refrigerated, or room temperature). The Investigational Drug Services pharmacy at Duke prepares products for infusion according to suppliers’ specifications and creates appropriate infusion records.
Image management
State-of-the-art, highly secure image-management and digital archival systems and world-class consultative services. Our accessible imaging labs offer advanced nuclear imaging, echocardiography, and spectral domain OCT scanning technologies.
Data integration
Data integration. Our informatics capabilities include extensive experience integrating phenotypic and biological marker data.
Volunteering
We firmly believe that your role as study volunteers in clinical research is crucial in the advancement of medicine. Without your participation, new ways to prevent, diagnose, and treat diseases cannot be achieved. You are our medical heroes!
Volunteer Recruitment
Tools that permit us to query the Duke medical record system and a proprietary research volunteer registry give us the ability to rapidly identify suitable study candidates after the appropriate approvals have been obtained.
Case Studies
We are able to initiate the regulatory process in parallel with contracting negotiations to expedite the time between contract signature and a study’s institutional approval.
We recognize how important you are to our mission and are committed to give back to you. When you participate in our studies, you will have the option to receive updates on study results and publications. You will dictate the frequency and method by which we reach out to you. This way, you will see quickly and directly the impact of your participation in accelerating new therapies to humans.
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.
Studies Currently Enrolling
Crohn’s Disease Patients Needed for Drug Study
Men and women diagnosed with Crohn’s Disease are needed to participate in a research study to assess how a drug being investigated as a potential treatment for Crohn’s Disease affects the absorption, metabolism, and activity of other common medications. Eligible participants will be 18 to 65 years of age. Participation will involve 17 visits to the Duke Early Phase Clinical Research Unit, and 3 of these visits will be inpatient admissions that last for 2 consecutive nights each. Enrolled participants will receive financial compensation.
For more information
Please contact the Duke Early Phase Clinical Research Unit at 919-613-6244 or DEPRUvolunteer@duke.edu.
Liver Cirrhosis Patients Needed
Men and women who are diagnosed with cirrhosis are needed to participate in a research study that will assess the effects of an investigational drug on people with cirrhosis compared to study volunteers with normal liver function. Eligible participants will have a confirmed diagnosis of cirrhosis and be between 18 and 70 years old. Participation will involve 5 outpatient visits and 1 inpatient admission to the Duke Early Phase Clinical Research Unit. Enrolled participants will receive financial compensation.
For more information
Please contact the Duke Early Phase Clinical Research Unit at 919-613-6244 or DEPRUvolunteer@duke.edu.
Research Study for Patients with Myasthenia Gravis
Men and women diagnosed with generalized myasthenia gravis are needed to participate in a research study for an investigational drug that is being developed as a potential treatment for MG. The study will examine the effectiveness of the drug in treating the symptoms of MG when it’s administered on an every-other-week basis. Eligible volunteers will be age 18 or older, have received a diagnosis of generalized myasthenia gravis, and who have not used a biologic drug in the past year. Study participation will last approximately 4 months and enrolled participants will receive compensation.
For more information
Please contact the Duke Early Phase Clinical Research Unit at 919-613-6244 or DEPRUvolunteer@duke.edu.
A Drug Study Targeting the Microbiome Needs Volunteers with Ulcerative Colitis
Men and women with ulcerative colitis are needed to participate in a study of a drug that’s being developed to improve the digestive bacterial healthy of UC patients. Eligible candidates will be UC patients with a documented history of intolerance or failure to respond to immunotherapy. The study is done on an outpatient basis and will last for approximately 14 months. Enrolled participants will receive financial compensation.
For more information
Please contact the Duke Early Phase Clinical Research Unit at 919-613-6244 or DEPRUvolunteer@duke.edu.