SOURCES SOUGHT
A -- Atherosclerosis Prevention Trial (APT)
- Notice Date
- 1/30/2006
- 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
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-NHLBI-SS-HC-APT
- Response Due
- 2/14/2006
- Archive Date
- 3/1/2006
- 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 a the Clinical Trials Coordinating Center (CTCC) for a large, international multicenter, randomized, double-blind trial comparing a strategy of lowering LDL-cholesterol (LDL-C) to <60mg/dl (or to the lowest achievable level) to a strategy of lowering LDL-C according to current guidelines in approximately 5,700 participants without known coronary or cerebrovascular disease but who are at elevated risk of coronary artery disease or stroke. Participants will be recruited over 2 years and followed for a minimum of 4 years. The CTCC in collaboration with the Steering Committee will select and coordinate a large network of clinics that can adequately recruit participants and follow them according to the study protocol. In addition to acquiring clinical data, the trial will assess subclinical disease, quality of life and cost-effectiveness. The contract will also provide funding for substudies of genetic predictors of treatment effect and susceptibility to development of atherosclerosis, as well as disease mechanisms. The CTCC will coordinate all aspects of the research and manage and analyze the patient and research data. The CTCC will manage and coordinate the efforts of the clinical sites. It is expected that over 100 sites in the United States and abroad will be required in order to enroll the large number of patients required in the study timeframe. The CTCC and representatives from the investigators and the NHLBI will form a Steering Committee that serves as the governing body of the program. The CTCC will prepare confidential reports and analyses for NHLBI review committees including a Protocol Review Committee (PRC) and Data Safety Monitoring Board (DSMB). Personnel should be knowledgeable and experienced in the conduct of large, complex multicenter international clinical trials in cardiovascular diseases or other randomized prospective clinical trials of similar complexity. This includes knowledge of and experience with data collection, management, monitoring, quality control, management of medication side effects and adverse reactions to drug therapy, data analysis and reporting. The CTCC should have access to clinical cardiology expertise. Institutional ability in dealing with regulatory agencies in the United States and abroad is also required. The CTCC will provide leadership in the statistical issues including the design of study protocols 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 also develop a plan for distribution of drugs to the clinical sites and coordination of activities with the Drug Distribution Center. The CTCC will be responsible for directing clinical sites in adjusting treatment dosages. The CTCC will coordinate the random assignment of patients to the trial; will be responsible for maintenance of data forms, computer systems for storage, retrieval and for ensuring the timely collection, entry and editing of the data. The CTCC should be able to provide continuous (24/7) medical and technical assistance to the clinical sites. The CTCC will also be responsible for coordinating communications among the various components of the study, scheduling meetings and conference calls of the study committees as needed. 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 8 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 that they possess the capabilities to perform this work must submit an original and three copies of a capability statement to this office by 4:30 PM EST on February 14, 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 Eileen Webster-Cissel, Contracting Officer, at the Contracting Office address listed above.
- Record
- SN00975445-W 20060201/060130211735 (fbodaily.com)
- Source
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