Cardiac surgery has been a spectacularly innovative field of medicine. The introduction of major innovations and ongoing incremental change have extended survival and improved quality of life for many patients suffering from cardiac disease. A rapid pace of innovation requires a rigorous infrastructure for clinical evaluation that provides timely assessments of the value of new treatments. The NHLBI, in collaboration with NINDS and CIHR, created the Cardiothoracic Surgical Trials Network (CTSN) to provide such an infrastructure. InCHOIR enthusiastically embraces the unique opportunity to work in partnership with the sponsors and clinical investigators as the CTSN DCC. Given our long-standing interest and experience in the design and analysis of cardiac surgery multicenter studies, we offer strong expertise to support clinical and scientific coordination, communication, logistical, and administrative functions necessary to promote this vital clinical research effort. The CTSN faces important challenges in designing and implementing trials, including the need to develop scientifically rigorous and feasible trials for evaluating surgical treatments for patients with cardiac disease that will serve as, and will be uniformly accepted as, the basis for treatment decisions. To meet these challenges we will provide leadership in the design of innovative exploratory clinical trials, exploiting our experience in designing novel clinical trials addressin specific needs not met by "off the shelf" designs;establish uniform outcome definitions;a web-based database for the collection and management of trial data and sharing of data among all investigators;training and monitoring of the clinical sites and core laboratories;clinical coordination, data management and quality assurance;administrative skills and the necessary leadership. We will promote the CTSN research objectives by facilitating the publication process, presenting at meetings and by developing an easily navigable public and private study informational website that provides important and timely information to the research community, practicing clinicians, and patients.

Public Health Relevance

Clinical trials are a critical step in translating discoveries into better treatments for people burdened by cardiac disorders. Such trials typically require cooperation and coordination among a broad range of investigators, patients, government agencies, and industry partners. The objective of the Cardiothoracic Surgical Trials Network (CTSN) model is to increase the effectiveness and efficiency of clinical research through shared infrastructure for important trials that will advance therapy for patients suffering from cardiac disease. (End of Abstract)

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01HL088942-07
Application #
8488804
Study Section
Special Emphasis Panel (ZHL1-CSR-H (F1))
Program Officer
Miller, Marissa A
Project Start
2007-07-01
Project End
2018-01-31
Budget Start
2013-09-01
Budget End
2014-01-31
Support Year
7
Fiscal Year
2013
Total Cost
$7,635,959
Indirect Cost
$1,427,524
Name
Icahn School of Medicine at Mount Sinai
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
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