School's International Center for Health Outcomes and Innovation Research (InCHOIR) Is Data Coordinating Center for Surgical Trials Network
NewYork-Presbyterian Hospital/Columbia University Medical Center Is Core Site Among 7 Participants
Jul 27, 2007
The International Center for Health Outcomes and Innovation Research (InCHOIR), a joint initiative of Columbia University Mailman School of Public Health and the Department of Surgery at Columbia's College of Physicians and Surgeons, has received a $23 million grant from the National Heart, Lung, and Blood Institute (NHLBI) to serve as the Data Coordinating Center for a newly established Cardiothoracic Surgery Investigations Network. The Network brings together leading medical institutions to develop multiple, multi-center trials of novel diagnostic and therapeutic interventions in the field of cardiac surgery in order to evaluate the safety and efficacy of these interventions as they move from laboratory science to broad clinical use.
NewYork-Presbyterian Hospital/Columbia University Medical Center is a core site of the new Cardiothoracic Surgery Investigations Network to assess the overall impact of heart surgeries – from survival and cost-effectiveness, to significant quality of life issues including impact on long-term brain function, such as cognition, memory and other neurological outcomes. It will receive $1.25 million over five-years for its participation as a clinical center. As part of the $23 million award to InCHOIR, additional funds will be shared among the seven clinical centers for protocol and patient-related costs over the five-year study period. NHLBI is awarding a total of $35 million in grants for the Cardiothoracic Surgery Investigations Network.
According to investigators, academic medicine has traditionally lacked a multi-center infrastructure for proof-of-concept trials looking at novel surgical and minimally invasive procedures. Recognizing this situation, NHLBI convened a working group, whose recommendations led to the creation of the Cardiothoracic Surgery Investigations Network.
"The introduction of major innovations, and ongoing incremental change, has extended survival and improved quality of life for the many patients suffering from cardiac disease," said Michael Parides, PhD, associate clinical professor of Biostatistics at the Columbia University Mailman School of Public Health and principal investigator of the Data Coordinating Center. "However, a rapid pace of innovation requires a rigorous infrastructure for clinical evaluation that can provide a timely assessment of the value of new treatments."
"This cardiothoracic surgery network is important because it will help answer the unanswered questions about which patients may benefit most from heart surgeries and when new technologies are appropriate or not," said Eric A. Rose, MD, chairman of the Department of Surgery at Columbia University Medical Center and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia, and lead investigator of the Columbia site for this trial. "As a core site of this network, we'll participate in its ongoing clinical trials as new technologies and questions arise."
Cardiac surgery has been an extraordinarily innovative field of medicine. In 2004 alone, there were over 350,000 coronary bypass operations in the U.S. "Clinical interventions, particularly in the area of cardiothoracic (CT) surgery are burgeoning; yet the assessment of novel surgical procedures poses methodological, ethical, logistical and analytical challenges," said Annetine Gelijns, PhD, professor of Health Policy and Management (in Surgery) at the Columbia University Mailman School of Public Health, co-director of InCHOIR, and co-principal investigator of the Data Coordinating Center. "InCHOIR has responded to these challenges by making novel contributions to trial design and analysis, including the use of composite endpoints, addressing barriers to enrollment, learning curves, and combining information from randomized and non-randomized sources."
In addition to NHLBI, funders of the Cardiothoracic Surgical Investigations Network include the National Institute of Neurological Disorders and Stroke, to assess the neurological impact of cardiac surgery, and the Canadian Institutes of Health Research/Institute of Circulatory and Respiratory Health.
"This exciting new collaboration between the National Institutes of Health and the Canadian Institutes of Health Research, as well as the seven network institutions, will help advance innovative surgical therapies from the laboratory to clinical care," said Elizabeth G. Nabel, MD, director, National Heart, Lung, and Blood Institute of the National Institutes of Health. "By enhancing the ability of research teams to evaluate new techniques, technologies, and devices, the network promises to improve the scientific basis of care in cardiovascular disease."
"The establishment of this network provides tremendous value – it enables the leaders in the field to share ideas, information, data, and results, and creates an infrastructure that facilitates early evaluation of innovations," said Alan Moskowitz, MD, professor of clinical Medicine at Columbia University's College of Physicians and Surgeons and professor of Health Policy and Management (in Surgery) at the Columbia University Mailman School of Public Health, co-director of InCHOIR, and co-principal investigator of the Data Coordinating Center. "Given InCHOIR's long-standing interest and experience in the design and conduct of cardiac surgery trials, we welcome the opportunity to lead the Data Coordinating Center for this highly pioneering collaboration, which will enhance the translation of findings to large-scale practice."
"We have collaborated for nearly a decade on the design and management of multi-center surgical trials that involve multiple endpoints, ranging from traditional clinical endpoints such as survival and adverse events, to patient-oriented outcomes such as functional status and quality of life, to overall societal outcomes such as economic impact," said Deborah Ascheim, MD, assistant professor of Medicine at Columbia University's College of Physicians and Surgeons and assistant professor of Health Policy and Management at the Columbia University Mailman School of Public Health, and head of InCHOIR's clinical trials group.
The leadership team of the Data Coordinating Center (DCC) consists of Michael Parides, PhD; Annetine Gelijns, PhD; Alan Moskowitz, MD, Deborah Ascheim, MD, J. Thomas Bigger, MD, Ronald Levitan, Dip Comp Sci, Jay P. Mohr, MD, and Ronald Lazar, PhD. At NewYork-Presbyterian/Weill Cornell, Mary Charlson, MD will oversee quality of life and functional status issues of study participants.
InCHOIR will be responsible for the trial design and protocol development, clinical coordination, data review and management, and monitoring of the Network's seven clinical sites. In addition to NewYork-Presbyterian Hospital/Columbia, sites participating in the phase II clinical trials include Duke University, Cleveland Clinic, Albert Einstein/Montefiore Medical Center, Emory University, University of Virginia, and Montreal Heart Institute.
"The goal of this kind of close examination is to help cardiac surgeons care for our patients from an evidence-based perspective," said Craig R. Smith, MD, chief, Division of Cardiothoracic Surgery at NewYork-Presbyterian Hospital/Columbia and the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons. "Since innovation in cardiothoracic surgery is so rapid, this is an opportunity to conduct thorough clinical evaluations of the surgical modalities to develop novel and innovative algorithms to select the right patient for the right procedures."
Widespread adoption of new surgical procedures has rarely benefited from timely evidence about their impact on patient outcomes and health resource consumption. These concerns were the driving factors in the founding of InCHOIR 10 years ago, and addressing them is the central mission of the Center. InCHOIR has been awarded over $50 million in clinical research funding over the last five years. NewYork-Presbyterian Hospital has also provided the Center with core support. Since its inception, InCHOIR has focused on the design, conduct, and analysis of multi-center trials of novel surgical and device-based interventions, particularly in cardiovascular and neurological diseases. InCHOIR's core faculty and staff of 30 have expertise in biostatistics, clinical trial operations, health economics and quality of life, and health policy analysis. For more information visit www.inchoir.org.
Mailman School of Public Health
The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 950 graduate students in pursuit of masters and doctoral degrees. Its students and more than 300 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. For more information, visit www.mailman.hs.columbia.edu.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists and public health professionals at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. For more information, visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital – based in New York City – is the nation's largest not-for-profit, non-sectarian hospital, with 2,335 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education, and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital is ranked with among the lowest mortality rates for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. At NewYork-Presbyterian Hospital/Columbia, more than 1,200 adult procedures are performed annually. For more information, visit www.nyp.org.