SOURCES SOUGHT
A -- Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy
- Notice Date
- 2/13/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- 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
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NHLBI-HV-08-03
- Response Due
- 2/28/2007
- Archive Date
- 3/15/2007
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health is conducting this market survey to identify small businesses with the capability to serve as the Clinical Trials Coordinating Center (CTCC) for a large, multicenter, double-blind, randomized, three-arm trial comparing a strategy of initiation of warfarin therapy based on an algorithm using both clinical and genotypic information on genetic variants in two genes known to influence warfarin metabolism (CYP2C9 and VKORC1 genes) versus a strategy of initiation of warfarin therapy based on an algorithm using only clinical information and versus a standard, guideline-based strategy. The trial will 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 trial Steering Committee will select and coordinate a network of clinical sites that can adequately select a large number of eligible participants, randomize and follow them according to a trial protocol, and obtain genotyping data. In addition to acquiring genotypic and clinical data, the trial will include detailed measurements of anticoagulation status, collection of detailed information on factors (nutritional, pharmacologic and others) influencing the anticoagulation status, and collection of quality of life and cost-effectiveness data. The trial will include a central laboratory to serve as a DNA repository for quality control of the local genotypic laboratories and DNA storage for future analyses. The study may also include core facilities for performance of future genetic analyses. Only one contract will be awarded for this project. The CTCC will coordinate all aspects of the research and manage and analyze patient and research (both clinical and genotypic) data. The CTCC will manage and coordinate the efforts of the clinical sites. It is expected that 15 clinical sites in the United States will be required to enroll the number of patients needed for the study. The Principal Investigators from the CTCC and clinical sites, and the NHLBI Project Officer 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). CTCC personnel must be knowledgeable and experienced in the design, conduct and analysis of pharmacogenomic studies, as well as in large, complex, multicenter clinical trials in 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 is required, and with quality control and analysis of genome-wide association and sequencing data. The CTCC will provide leadership in the statistical issues including the design of a study protocol and analysis of study data. The CTCC will be responsible for the design or 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 also 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. 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 IS NOT A REQUEST FOR PROPOSALS (RFP) AND NO RFP IS AVAILABLE AT THIS TIME. Small businesses who believe they possess the capabilities to perform this work must submit an original and three copies of a capability statement to this office by 4:00 PM EST on February 28, 2006. Responses to this market survey should include pertinent information and meet the requirements of this notice. All information submitted in response to this notice must arrive on or before the closing date and time. Capability statements should be submitted to the following address: Lawrence M. Butler, Contracting Officer, National Heart, Lung, and Blood Institute, National Institutes of Health, Rockledge 2 Building, Room 6104, 6701 Rockledge Drive, MSC 7902, Bethesda, MD 20892-7902.
- Record
- SN01231060-W 20070215/070213220219 (fbodaily.com)
- Source
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