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A -- Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy

Solicitation Number: NHLBI-HV-08-03
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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NHLBI-HV-08-03
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Solicitation
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Added: March 23, 2007
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health is interested in soliciting proposals from all interested organizations to serve as the Clinical Trial Coordinating Center (CTCC) for a large, multicenter, double-blind, randomized trial comparing three possible approaches to guiding warfarin therapy initiation: 1) initiation of warfarin therapy based on an algorithm using clinical information and the individualís genotype relative to two genes known to influence warfarin metabolism (CYP2C9 and VKORC1 genes); 2) initiation of warfarin therapy based on an algorithm using only clinical information; and 3) a standard, guideline-based initiation strategy. The trial would randomize approximately 2,000 participants with any indication for chronic long term anticoagulation and no previous treatment with warfarin. Participants will be recruited over 18 months and followed for one year. The CTCC in collaboration with the Steering Committee will identify, select, subcontract and coordinate a network of clinics that can adequately select a large number of eligible participants, randomize and follow them according to the study protocol, and obtain the genotyping data. In addition to acquiring genotypic and clinical data, the trial will include detailed measurements of anticoagulation status, collect detailed information on factors (nutritional, pharmacologic and others) influencing the anticoagulation status, and collect quality of life and cost-effectiveness data. The trial will include a central laboratory/core facility to serve as DNA repository for quality control of the local genotypic laboratories and DNA storage for future analyses. The core facility will also collect and store blood for both immediate and future studies of biomarkers contributing to the bleeding and thromboembolic risk in trial participants. These studies may include, but are not limited to, DNA extraction and analysis for investigation of relevant pathway genes, genome-wide association, and sequencing. The CTCC will identify, select, subcontract with, and oversee a subcontract for the Central Laboratory. Only one contract will be awarded for this project.

The CTCC will coordinate all aspects of the research and manage and analyze the patient and research (both clinical and genotypic) data. The CTCC will manage and coordinate the efforts of the clinical sites. It is expected that approximately 15 sites will be required to enroll the large number of patients needed for the study. The Principal Investigators from the CTCC and clinical sites, the NHLBI Project Officer and a National Human Genome Research institute (NHGRI) representative will form a Steering Committee that serves to provide scientific direction to the program. The CTCC will prepare confidential reports and analyses for NHLBI review committees including a Protocol Review Committee (PRC) and Data and Safety Monitoring Board (DSMB). Personnel must be knowledgeable and experienced in the design, conduct and analysis of pharmacogenomic studies, as well as in large, complex multicenter clinical trials for the prevention and treatment of thromboembolic diseases or other randomized prospective clinical trials of similar complexity. Medical and scientific expertise in pharmacogenomics and in clinical conditions requiring oral anticoagulation, in data collection, management, monitoring, quality control, management of medication side effects and adverse reactions to drug therapy, data analysis and reporting is required. Institutional ability in dealing with regulatory issues involving genetic analyses, with quality control and analysis of genome-wide association and sequencing data is required. The CTCC will provide leadership in the statistical issues including the design of the study protocol and analysis of study data. The CTCC will be responsible for the design, selection, and management of data collection tools and ensuring quality control, including the design and management of a study website. The CTCC will coordinate the randomization of patients into the trial and will be responsible for maintenance of data forms, computer systems for storage and retrieval, and for ensuring the timely collection, entry and editing of the data. The CTCC should be able to provide continuous assistance to the clinical sites for issues related to study execution. The CTCC will be responsible for coordinating communications among the various components of the study, and for scheduling meetings and conference calls of the study committees as needed. The CTCC will also organize the PRC and DSMB meetings and prepare statistical reports and the minutes of these meetings. The CTCC in collaboration with the NHLBI will arrange and conduct site visits to the clinical sites and central laboratory. This acquisition has been designated as full and open competition. The applicable NAICS code is 541710 and the size standard is 500 employees. It is anticipated that one award will be made for a period of 3 1/2 years. The contract will be a cost-reimbursement, completion-type. THIS PRESOLICITATION NOTICE IS NOT THE REQUEST FOR PROPOSALS (RFP); the Request for Proposals must be downloaded from the NIH Web Site, and will be available on or about April 8, 2007, at the following internet address at the FedBizOpps Website: http//www.fedbizopps.gov and at the NHLBI Website: http//www.nhlbi.nih.gov/funding inits/index.htm. The estimated due date for proposals is on or about June 20, 2007.

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Solicitation 1

Type:
Solicitation
Posted Date:
April 12, 2007
20070412094706.zip (354.93 Kb)
Description: All Files

Amendment 1

Type:
Mod/Amendment
Posted Date:
May 17, 2007
Description: All Files
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Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
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Larry Butler, Contract Specialist, Phone (301) 435-0326, Fax (301) 480-3338, Email lbutler@mail.nih.gov - Pamela Lew, Chief, HLVD Contracts Branch, Phone (301) 435-0331, Fax (301) 480-3338, Email pl116x@nih.gov