National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUS -- COORDINATING CENTER POC John Taylor, Contracting Officer. 301-435-0350 The National Heart, Lung, and Blood Institute is conducting a market survey to assess the availability and potential technical capability of small business firms as defined by Standard Industrial Classification Code (SIC) 7375, $18.0 million, to perform as a Coordinating Center for a multi-center clinical trial (estimated eight clinical networks comprising an estimated 45 clinical centers) designed to determine if the rate of major cardiovascular events in patients with Type 2 diabetes mellitus (DM) can be reduced by intensive blood glucose control, with or without drugs that lower insulin resistance, or by intensive lipid and blood pressure (BP) control. In addition, the study will also examine the cost effectiveness of the various intervention approaches. A number of investigator-initiated ancillary sub-studies are also anticipated, including a comparison of the various intervention approaches on quality of life. A planned total of 10,000 patients will be randomized into six intervention or control groups (3-by-2 factorial design) for a nine-year study (patient treatment and follow-up of four to seven years). This will be a new award. The Coordinating Center will have responsibility for the overall coordination, monitoring, and central management of all activities of the study, including communications, study protocol, manual of operations, data collection and quality control, and data analysis and reporting. The Coordinating Center will also be charged with the responsibility of competitively selecting, after contract award, a Central Blood Laboratory, Central ECG Reading Center, and Drug Distribution Center to perform as subcontracts to the Coordinating Center. Small business firms having demonstrated research and development capabilities for ongoing design, coordination, and analysis of long-term, large multi-center intervention studies related to cardiovascular disease (CVD) are invited to submit capability statements. Information furnished should establish (1) qualifications of medical, scientific, technical, and administrative staff with experience pertinent to the operation of a Coordinating Center for a large multi-center randomized clinical trial in CVD with clinical outcomes; (2) the ability to coordinate, monitor, and manage study activities, including those related to data collection, management, and analysis; (3) evidence of administrative and scientific leadership in Coordinating Center activities; (4) the availability of facilities, space, and equipment necessary for the conduct of this study; and (5) the firm's status as a small business under SIC code 7375. This is not a Request For Proposals (RFP). The RFP release date is pending. Three copies of the material requested above must be submitted within thirty (30) calendar days from the date of publication of this announcement in the Commerce Business Daily (CBD). Posted 11/05/98 (W-SN269117). (0309)

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