| Duke Clinical Research Institute |
| Overview | Devices Unit Research Track |
The Duke Clinical
Research Institute (DCRI) is devoted to conducting multi-center
clinical research with a mission to develop and share knowledge that improves
the care of patients through innovative clinical research. The largest academic research
organization in the world, the DCRI is known for its pioneering research in
cardiology but performs clinical research across the spectrum of diseases, ranging from:
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Phase I through Phase IV clinical trials
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Outcomes and quality research
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Registries of more than 100,000 patients
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Economic and quality of life studies in populations spanning more than 20 therapeutic areas
The DCRI grew out of
the Duke Databank for Cardiovascular Diseases, which is one of the world’s
largest repositories of follow-up on patients who have documented coronary
heart disease (more than 200,000 patients have been enrolled to
date). The DCRI has evolved into
an organization with major efforts in clinical trials, outcomes research, and
health policy, and the DCRI expanded beyond the cardiovascular therapeutic area
beginning in 1996.
The DCRI faculty includes clinician researchers, biostatisticians, health economists, and
health services researchers. Currently, the DCRI comprises approximately 900
employees, including more than 100 faculty from all disciplines.
Most DCRI researchers are also active practicing physicians,
studying the application of research to patient care.Research Accomplishments
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Conducted studies at more than 3592 sites in 63 countries
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More than 540,000 patients enrolled in DCRI studies
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More than 4600 publications in peer-reviewed journals
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More than 270 Phase I-IV trials and outcomes research projects completed
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More than 5000 investigators worldwide
For more information on the DCRI and its research, visit the DCRI Web site.
Training Program
The DCRI
offers a living laboratory for investigators of the future by combining faculty
interests in specific research questions with the multifaceted environment
needed to do outcome based studies.
Trainees at the DCRI have the opportunity
to experience firsthand the features of conducting domestic and international
clinical trials and outcomes studies including activities such as protocol
development, study operations, continuing medical education curricula development,
clinical events adjudication, as well as operational functions such as project and
data management, site management, and utilization of information technology specific
to multi-center clinical research studies.
Each cardiovascular
trainee at the DCRI develops a relationship with a primary mentor who bears the
responsibility of guiding the trainee’s career development. Within
cardiovascular medicine, trainees are recommended to focus upon either cardiovascular
outcomes or clinical trials. However, trainees who focus on outcomes generally
also work with at least one clinical trial, and clinical trial trainees
generally conduct at least one database project. The mentor is expected to
assist the fellow in developing a broad range of experiences with different
types of faculty, not just to have the fellow work in his or her own research
projects.
DCRI fellows attend a weekly DCRI Clinical Research Conference in
which fellows, faculty and visiting researchers present work in progress. The
fellows also invite external leaders in cardiovascular medicine to conduct
two-day visiting professor sessions including intensive small seminars with the
fellows.
A critical component
of the training program is the intense interaction between the clinician
researchers and statisticians. The philosophy of the training program is that the
most successful investigators in cardiovascular medicine will be able to
combine superior knowledge of clinical cardiology with quantitative principles
in an interactive, teamwork oriented environment.
Cardiovascular fellows also have the opportunity
to participate in coursework for the Clinical Research Training Program to
obtain a Masters in Health Sciences in Clinical Research during their research
fellowship at DCRI. This program offers
in-depth training regarding biostatistics, clinical research design and
methodology, cost-effectiveness research, and health economics.
The clinical research
training offered to cardiovascular fellows at DCRI is unparalleled and
represents a distinct advantage for trainees interested in a career in academic
medicine and clinical investigation.
Selected
Publications
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Felker GM, Gattis WA, Adams KF, O'Connor CM. Anemia as a risk factor and therapeutic target in heart failure. Journal of the American College of Cardiology 2004; 44: 959-966.
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Petersen JL, Mahaffey KW, Hasselblad V, Antman EM, Cohen M, Goodman SG, Langer A, Blazing MA, Le-Moigne-Amrani A, deLemos JA, Nessel CC, Harrington RA, Ferguson JJ, Braunwald E, Califf RM. Efficacy and Bleeding Complications Among Patients Randomized to Enoxaparin or Unfractionated Heparin for Antithrombin Therapy in Non-ST-Segment Elevation Acute Coronary Syndromes. JAMA 2004;292:89-96.
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Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. Relationship of Blood Transfusion and Clinical Outcomes in Patients with Acute Coronary Syndromes. JAMA 2004;292:1555-1562.
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Sonel AF, Good CB, Mulgund J, Roe MT, Gibler WB, Smith SC Jr., Cohen MG, Pollack CV Jr., Ohman EM, Peterson ED, for the CRUSADE Investigators. Racial variations in treatment and outcomes of black and white patients with high risk non-ST-elevation acute coronary syndromes: insights from CRUSADE. Circulation 2005;111:1225-1232.
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Bardy GH, Lee KL, Mark DB, et al., for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure. N Engl J Med 2005;352:2146.




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