The DCRI provides the infrastructure to design, initiate, conduct, and report interdisciplinary and collaborative clinical research to help understand human conditions, develop new therapies, and translate basic research findings into patient care.
Early Phase Research at Duke Clinical Research Unit (DCRU)
The Duke Clinical Research Unit (DCRU) is a 40-bed, state-of-the-art clinic that provides the infrastructure to support investigators in the design, initiation, and conduct and reporting of interdisciplinary and collaborative clinical and translational research to help understand human conditions, translate basic research findings into patient care, and develop new therapies.
Phase III-IV
The DCRI provides the insight, experience, and efficiency to optimize your research investment. Our late-phase clinical trials teams understand that there are many study and design variables and will align and customize their processes to deliver cost-effective results that meet your objectives.
These teams include specially trained and dedicated project managers as well as experts in health outcomes, epidemiology, biostatistics, and post-marketing regulations.
Outcomes Research and Assessment
With the rapid-fire introduction of new health care technologies and the end of the “open checkbook” era of medicine, providers, patients, and payers face an urgent need for high-quality outcomes research. Housed in one of the world’s premier academic research organizations, Outcomes at the DCRI leads the nation in the collection and analysis of economic and quality-of-life data for the purpose of addressing reimbursement-related barriers to the adoption of new therapies. We are also a recognized leader in the burgeoning field of quality of care.
Our services cover the spectrum of outcomes related research. We have conducted large-scale studies across a range of therapeutic areas, from breast cancer to cardiovascular disease. We have developed decision models for seriously ill patients and have substantial experience coordinating clinical data registries, assessing provider performance, and developing methodologies for provider profiling.
We also help to maintain the world’s oldest and largest ongoing database for cardiovascular disease and have developed one of the largest secondary administrative data repositories in the country for analysis of epidemiologic and practice-pattern issues.
With 21 full-time faculty and 100 full-time statisticians, project managers, and research/support staff, Outcomes at the DCRI stands at the ready to evaluate outcomes and costs in your Phase 2 through 4 clinical trials and observational research studies.
The DCRI is a comprehensive academic research organization (ARO) and the only one of its kind that can offer all the services of a commercial contract research organization (CRO) with the academic credibility and expertise of an academic research institute.
From planning to execution to publishing results, the DCRI excels at every facet required for a speedy, effective research project. Our unique operational model ensures that all aspects of a project account for both our dedication to patients and the business needs of our sponsors. By joining skilled project leaders with extensive clinical experience and the country’s top physician-investigators right from the start, our research is tightly focused, efficient, and effective.
Our abilities do not end with a project’s conclusion. We know that successful research in today’s climate also includes post-approval studies for a complete submission package and a communications strategy for effective dissemination of results.
What do our scientific leaders do?
Our scientific leaders develop ideas and protocols for clinical research projects designed to be implemented in the current practice setting—i.e., maximize efficiencies for protocol implementation and/or the ability to implement a protocol into the targeted practice setting and within the context of other therapies.
-Author manuscripts for peer-reviewed journals
-Cover the 24-hour Clinical Helpline
-Act as principal investigators for DCRI projects, providing access to the resources and networks available within a large academic medical institution
-Make scientific presentations at professional meetings
-Provide expert support for clinical program development plans and FDA and international regulatory meetings.
-Develop ideas and protocols for clinical research projects designed to be implemented in the current practice setting
-Consult with site investigators on medical and/or enrollment issues
-Train project team on protocol and clinical science