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10. Research and Development Contracts

• NHLBI Total Research and Development Contract Obligations: Fiscal Years 1996–2006
• Major NHLBI Research and Development Contracts by Program
• Heart and Vascular Disease Program
• Lung Disease Program
• Blood Diseases and Resources Program

NHLBI Research and Development Contract Obligations*: Fiscal Years 1996–2006

Text-only With Data Points

* For detailed data on contract-supported clinical trials, see Chapter 11.

NHLBI Total Research and Development Contract Obligations: Fiscal Years 1996–2006

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Major NHLBI Research and Development Contracts by Program

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Heart and Vascular Diseases Program

Atherosclerosis Risk in Communities (ARIC), Initiated in Fiscal Year 1985

The ARIC program is a large-scale, long-term program that is measuring associations of CHD risk factors with atherosclerosis by race, gender, and geographic location. It focuses on early detection of CVD before symptoms, heart attacks, or strokes occur. The project consists of two groups: a community surveillance component and a cohort component from four communities. Three of the cohort components represent the racial mix of their community, whereas the fourth is exclusively black.

Obligations

Funding History:
   Fiscal Year 2006—$6,344,206
   Fiscal Years 1985–2005—$121,966,244
Total Funding to Date—$128,310,450

Candidate Gene Association Resources, Initiated in Fiscal Year 2006

This program establishes a genotyping and bioinformatics center to perform high-throughput genotyping for candidate gene association studies in up to 50,000 participants, and a genome-wide association study in about 500 disease cases and 1,000 controls. The data will be combined with available phenotype data to form a genotype-phenotype resource for public use. DNA for the 50,000-person sample will be collected from multiple NHLBI cohort studies that have stored samples and available data on a wide array of heart, lung, blood, and sleep phenotypes.

Obligations

Funding History:
   Fiscal Year 2006—$2,789,517
Total Funding to Date—$2,789,517

Cardiovascular Health Study (CHS), Initiated in Fiscal Year 1988

The CHS is a population-based, longitudinal study of risk factors for development and progression of CHD and stroke in elderly adults. Extensive data and samples have been collected from nearly 6,000 participants since 1989–1990. The objective for the current CHS: Transition Phase is to enhance use of the data and samples by the scientific community during a transition period from a contract-funded, NHLBI-directed program to one directed by a steering committee of investigators with independent research support. Seventeen percent of the participants are from minority populations.

Obligations

Funding History:
   Fiscal Year 2006—$930,000
   Fiscal Years 1988–2005—$75,886,177
Total Funding to Date—$76,816,177

Coronary Artery Risk Development in Young Adults (CARDIA), Initiated in Fiscal Year 1984

CARDIA is a long-term study examining the evolution of CVD risk factors in a cohort of black and white adults, aged 18 to 30 years in 1985–1986. The study examines risk for heart and lung disease and diabetes by collecting information on body composition, physical activity and lifestyle, genetics, serologic and metabolic components, inflammatory markers, and other subclinical markers of disease. Fifty percent of the participants are black.

Obligations

Funding History:
   Fiscal Year 2006—$6,881,765
   Fiscal Years 1984–2005—$71,838,396
Total Funding to Date—$78,720,161

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DNA Resequencing and Genotyping, Initiated in Fiscal Year 2004

The purpose of this program is to obtain rapid, reliable, and cost-efficient DNA sequencing and genotyping of candidate genomic regions potentially important in the disease pathways of heart, lung, and blood diseases and sleep disorders. This information will assist ongoing investigations of genetic components involved in the causes, variable outcome, and progression of the diseases and disorders.

Obligations

Funding History:
   Fiscal Year 2006—$7,000,000
   Fiscal Year 2004-2005—$11,000,000
Total Funding to Date—$18,000,000

Framingham Heart Study

The orginal Framingham Heart Study was designed as a longitudinal investigation of constitutional and environmental factors influencing the development of CVD in individuals free of these conditions at the outset. Of the original 5,209 subjects, about 500 members remain alive. In 1971, the Framingham Offspring Study was initiated to assess familial and genetic factors associated with CHD. More than 5,000 offspring (and their spouses) were included. A third-generation cohort consisting of 3,500 grandchildren has been added to permit examination of numerous hypotheses about the genetic contribution to CVD and CVD risk factors. Additional goals include identifying new risk factors for cardiovascular, lung, and blood diseases and developing new imaging tests that can detect very early stages of coronary atherosclerosis in otherwise healthy adults.

Obligations

Funding History:
   Fiscal Year 2006—$10,907,043
   Fiscal Years 1983–2005—$62,166,638
Total Funding to Date—$73,073,681

Genetically Triggered Thoracic Aortic Aneurysms and Other Cardiovascular Conditions (GENTAC): National Registry, Initiated in Fiscal Year 2006

The purpose of this program is to establish a national registry to enable investigators to determine the best medical practices to advance the clinical management of genetic thoracic aortic aneurysms and other cardiovascular complications associated with connective tissue diseases such as Marfan Syndrome.

Obligations

Funding History:
   Fiscal Year 2006—$1,391,748
Total Funding to Date—$1,391,748

Hispanic Community Health Study (HCHS), Initiated in Fiscal Year 2006

The purpose of this study is to identify risk factors for cardiovascular and lung diseases in Hispanic populations living in the United States and determine the role of acculturation in their development and prevalence. The program will support a multicenter, 6.5-year epidemiologic study comprising approximately 16,000 participants of Hispanic origin (4,000 at each of 4 sites), aged 18 to 74 years.

Obligations

Funding History:
   Fiscal Year 2006—$2,900,000
Total Funding to Date—$2,900,000

Jackson Heart Study (JHS), Initiated in Fiscal Year 1998

The JHS is a single-site epidemiologic study of CVD in blacks, similar to established studies in Framingham, Massachusetts, and Honolulu, Hawaii, with primary goals of identifying risk factors for development and progression of CVD; enhancing recruitment, cohort retention, and scientific productivity of the existing Jackson site of the ARIC study; building research capabilities at minority institutions; developing partnerships between minority and majority institutions; and expanding minority investigator participation in large-scale epidemiologic studies.

Obligations

Funding History:
   Fiscal Year 2006—$3,535,576
   Fiscal Years 1998–2005—$20,219,989
Total Funding to Date—$23,755,565

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Multi-Ethnic Study of Atherosclerosis (MESA), Initiated in Fiscal Year 1999

The purpose of this study is to investigate the prevalence, correlates, and progression of subclinical CVD, i.e., disease detected noninvasively before it has produced clinical signs and symptoms, in a population that is 38 percent white, 28 percent black, 22 percent Hispanic, and 12 percent Asian.

Obligations

Funding History:
   Fiscal Year 2006—$8,563,705
   Fiscal Years 1999–2005—$54,269,999
Total Funding to Date—$62,833,704

Pediatric Circulatory Support, Initiated in Fiscal Year 2004

The purpose of this program is to establish multidisciplinary teams to develop innovative circulatory assist devices or other bioengineered systems for infants and children with congenital and acquired CVD who experience cardiopulmonary failure and circulatory collapse.

Obligations

Funding History:
   Fiscal Year 2006—$5,959,141
   Fiscal Year 2004–2005—$8,581,202
Total Funding to Date—$14,540,343

Proteomics Initiative, Initiated in Fiscal Year 2002

The purpose of this program is to establish highly interactive, multidisciplinary centers to enhance and develop innovative proteomic technologies directed to relevant biologic questions associated with heart, lung, blood, and sleep health and disease. Scientists will focus on the cells’ protein machinery directed toward understanding the molecular basis of the causes and progression of heart, lung, and blood diseases and sleep disorders and identifying targets for therapeutic interventions.

Obligations

Funding History:
   Fiscal Year 2006—$18,740,000
   Fiscal Years 2002–2005—$78,893,890
Total Funding to Date—$97,633,890

Registry for Mechanical Circulatory Support, Initiated in Fiscal Year 2005

The purpose of this program is to establish a data and clinical coordinating center to manage a registry of patients receiving a mechanical circulatory support device (MCSD) to treat heart failure. The registry will collect and analyze clinical and laboratory data and tissue samples from patients who receive MCSDs as destination therapy for end-stage heart failure at 60 to 70 participating hospitals.

Obligations

Funding History:
   Fiscal Year 2006—$1,585,877
   Fiscal Year 2005—$1,215,702
Total Funding to Date—$2,801,579

SNP Health Association Resource (SHARE), Initiated in Fiscal Year 2006

The purpose of this program is to identify genetic variants associated with heart, lung, and blood diseases and sleep disorders through application of large-scale, single nucleotide polymorphism (SNP) genotyping for genome-wide association analyses. In collaboration with the National Center for Biotechnology Information, the Institute is developing a public-use data resource to integrate genome-wide genotypic information with phenotypic information from multiple NHLBI studies.

Obligations

Funding History:
   Fiscal Year 2006—$2,000,000
Total Funding to Date—$2,000,000

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Translational Behavioral Science Research Consortium, Initiated in Fiscal Year 2002

The purpose of this program is to establish a consortium of interdisciplinary basic and applied social scientists to conduct research related to developing and testing theories from the behavioral or social sciences concerning cognitive, affective, motivational, developmental, and other factors and processes underlying human behavior. Acquired knowledge will be used to develop and test methods to encourage individuals to adopt and maintain a healthy lifestyle and manage behavioral risk factors for heart, lung, and blood diseases and sleep disorders.

Obligations

Funding History:
   Fiscal Year 2006—$0
   Fiscal Years 2002–2005—$20,430,569
Total Funding to Date—$20,430,569

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Lung Diseases Program

Lung Tissue Research Consortium, Initiated in Fiscal Year 2004

The purpose of this program is to establish a consortium for collecting lung tissues and preparing and distributing them for research. Scientists seek to improve management of lung diseases by increasing understanding of the pathogenetic mechanisms of lung diseases through molecular histopathological studies on tissues with and without disease. Primary emphases are on COPD and idiopathic pulmonary fibrosis.

Obligations

Funding History:
   Fiscal Year 2006—$12,598,812
   Fiscal Year 2004–2005—$10,499,994
Total Funding to Date—$23,098,806

Tuberculosis Curriculum Coordinating Center, Initiated in Fiscal Year 2003

The purpose of this program is to establish a consortium of five Tuberculosis Curriculum Centers to strengthen and increase access to the best ongoing educational and training opportunities in TB for medical, nursing, and allied health schools, especially those that provide primary care to communities where TB is endemic and the population is at high risk.

Obligations

Funding History:
   Fiscal Year 2006—$1,125,000
   Fiscal Years 2003–2005—$3,750,000
Total Funding to Date—$4,875,000

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Blood Diseases and Resources Program

Iron Overload and Hereditary Hemochromatosis, Initiated in Fiscal Year 2000

The purpose of this program is to determine the prevalence; genetic and environmental determinants; and potential clinical, personal, and societal impact of iron overload and hereditary hemochromatosis in a multicenter, multiethnic, primary care-based sample of 100,000 adults. Information derived from the study will be used to determine the feasibility and potential individual and public health benefits and risks of primary care-based screening and intervention for iron overload and hereditary hemochromatosis.

Obligations

Funding History:
   Fiscal Year 2006—$469,227
   Fiscal Year 2000–2005—$25,979,773
Total Funding to Date—$26,449,000

Maintenance of Animals for Hepatitis or AIDS Research, Initiated in Fiscal Year 1992

The purpose of this program is to maintain an NHLBI chimpanzee colony that can be used in experiments with transfusion-transmitted infectious agents (hepatitis C virus (HCB), hepatitis B virus (HBV), and HIV) for which the chimpanzee is the only known animal model.

Obligations

Funding History:
   Fiscal Year 2006—$160,474
   Fiscal Year 1992–2005—$8,805,530
Total Funding to Date—$8,966,004

Maintenance of NHLBI Biological Specimen Repository, Initiated in Fiscal Year 1998

The purpose of this project is to establish an NHLBI Biological Specimen Repository for blood specimens from Institute-supported research. The Repository monitors storage, labeling, and testing of the specimens, as well as administers safe shipment of precise sample aliquots to approved investigators for future studies.

Obligations

Funding History:
   Fiscal Year 2006—$1,031,572
   Fiscal Years 1998–2005—$6,594,342
Total Funding to Date—$7,625,914

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Production of Recombinant B19 Parvovirus Capsids, Initiated in Fiscal Year 1998

The purpose of this program is to manufacture clinical-grade recombinant protein Parvovirus B19 vaccine for use in a Phase I/II clinical trial to be conducted by the NHLBI.

Obligations

Funding History:
   Fiscal Year 2006—$666,950
   Fiscal Year 1998–2005—$2,483,750
Total Funding to Date—$3,150,700

Retrovirus Epidemiology Donor Study (REDS), Initiated in Fiscal Year 1989

The purpose of this study is to conduct epidemiologic, laboratory, and survey research on volunteer blood donors within the United States to ensure the safety and availability of the blood supply. The studies will examine the risks of transfusion-transmissible infections, their trends, and ways to reduce infection risks; HIV, HTLV, HCV, and HBV test screening methodologies; donor characteristics, behaviors, and donation return patterns of U.S. blood donors; and the effectiveness and safety of various strategies to increase the U.S. blood supply.

Obligations

Funding History:
   Fiscal Year 2006—$8,955,049
   Fiscal Years 1989–2005—$86,865,125
Total Funding to Date—$95,820,174

Sickle Cell Disease Health-Related Quality of Life Questionnaire, Initiated in Fiscal Year 2005

The purpose of this project is to develop a psychometrically sound and clinically useful health-related quality-of-life instrument and related materials for use in sickle cell clinical trials and outcomes research among adults with SCD, and to assist researchers who are early users of the instrument and materials.

Obligations

Funding History:
   Fiscal Year 2006—$708,000
   Fiscal Year 2005—$584,008
Total Funding To Date—$1,292,008

Somatic Cell Therapy Processing Facilities, Initiated in Fiscal Year 2003

This program is designed to develop novel somatic cellular therapies in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials for heart, lung, and blood diseases and sleep disorders. The goal is to provide rapid, safe translation of basic research ideas into clinical practice.

Obligations

Funding History:
   Fiscal Year 2006—$6,139,526
   Fiscal Years 2003–2005—$15,576,209
Total Funding to Date—$21,715,735

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