National Heart, Lung and Blood Institute, Two Rockledge Centre, Room 6128, 6701 Rockledge Drive, Mail Stop Code 7902, Bethesda, MD 20892-7902

A -- MAGNESIUM IN CORONARIES (MAGIC) POC Peggy Mills, Contract Specialist, (301)435-0351 or Donna Berkowitz, Contracting Officer, (301)435-0349 R -- MAGNESIUM IN CORONARIES Peggy Mills, Contract Specialist (301) 435-0351 or Donna Berkowitz, Contracting Officer (301) 435-0349. 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 Code (SIC) 8731 (500 employees) to perform as a Clinical Trial Center (CTC) for a large multicenter clinical trial. The purpose of the Magnesium in Coronaries (MAGIC) study is to determine whether patients with suspected acute myocardial infarction and who are at a high risk for mortality can benefit from early adm inistration of intravenous magnesium. Patients undergoing reperfusion therapy (thrombolytic therapy or primary angioplasty) will be eligible provided magnesium can be administered before or at the same time as the reperfusion therapy. Patients with acute myocardial infarction who do not receive thrombolytic therapy or primary angioplasty will be eligible if they canbegin magnesium infusion within 6 hours of the onset of symptoms. The primary endpoint will be all cause mortality at 30 days following the index event. Secondary endpoints will include development of cardiogenic shock, ventricular fibrillation, congestive heart failure, and the need for a temporary pacemaker. The estimated sample size is 10,400 subjects with approximately 300 clinic sites participating in this three year trial. The Clinical Trial Center will have the following responsibilities: 1) a leadership role in developing the manual of operations and data collection forms, 2) provide 24-hour on call assistance by a medical doctor to the clinical sites, 3) obtain single project assurance numbers from the Department of Health and Human Services, National Institutes of Health, Office of Protection for Research Risks, 4) obtain clearances required by the Office of Management and Budget under the Paperwork Reduction Act, 5) develop procedures for random allocation of patients to treatment groups, 6) design and implement procedures to evaluate clinical investigators, 7) develop procedures for and provide on-going quality control and manageme nt of study data, 8) train clinical staff on procedures required by the study protocol, 9) monitor adverse patient effects, 10) prepare clinical, technical, and statistical reports in the form needed by a Data and Safety Monitoring Board to evaluate the safety of the protocol to patients, 11) develop procedures to reimburse clinical investigators for accepted data forms, such as participant randomizations, events, follow-up forms, and death certificates, 12) develop appropriate methods of analysis and prese ntation of data collected during the course of the study. Small business firms with demonstrated experience performing the tasks described in items 1-12 above in large clinical trials are invited to submit capability statements. The capability statements must provide evidence of experience in performing the responsibilities of the CTC described in items 1-12 above and demonstrate the following: 1) the availability and qualifications of the following professional staff needed to perform the work: medical, technical, scientific, and administrative staff with expertise in clinical cardiology, management of myocardial infarction, congestive heart failure, data collection, data monitoring, data analysis, quality control, management of side effects, and adverse reactions to medical therapy; 2) the ability to quickly modify the labor mix to meet changing levels of demand; 3) evidence of prior administrative and scientific leadership as a Clinical Trial Center in coordinating, monitoring, and managing a clinical t rial for cardiovascular disease similar to MAGIC (10,400 participants and 300 clinical sites); 4) evidence of prior experience in developing a suitable approach to protocol development and implementation for a study similar to MAGIC, including accessing and overseeing clinical investigators with the ability to enroll and follow adequate numbers of patients including womenand minorities, 5) evidence of prior experience in developing a suitable plan for the proposed methods of coordinating, monitoring, and c entral management of all activities required by the study protocol in a study similar to MAGIC, including procedures, randomization of patients, coordinating of data collection, and specialized tests, 6) experience in analysis and interpretation of medical data for purposes of ensuring patient safety; 7) access to a large capacity computer facility and networking to remote terminals; 8) evidence of publishing scientific papers in a collaborative study and the current availability of expert staff to publish such papers; and 9) the firm's status as a small business under SIC 8731: Commercial, Physical and Biological Research. Capability statements in response to this sources sought synopsis that do not provide sufficient information for evaluation will not be considered. This is not a Request for Proposals (RFP). The RFP release date is pending. See numbered note #13. Provide three copies of your capability statement within thirty (30) calendar days from the date of publication of this announcement in the C ommerce Business Daily (CBD). (0119)

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