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

A -- STUDY OF CORONARY REVASCULARIZATION AND THERAPEUTICS EVALUATIONS (SOCRATES) SOL NHLBI-HC-98-33 DUE 091598 POC William M. Stevens, Contract Specialist, (301) 435-0345 or, John C. Taylor, Contracting Officer, (301) 435-0345 E-MAIL: stevensw@gwgate.nhlbi.nih.gov, stevensw@gwgate.nhlbi.nih.gov. 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) or 8733 (5 Million dollars) to perform as a Clinical Data Coordinating Center (CDCC) for a large multicenter clinical trial. The purpose of the SOCRATES study is to conduct a multicenter randomized trial to determine the long-term benefits and risks of anti-ischemic strategies in patients with stable coronary heart disease (CHD) and objective evidence of ischemia who are eligible for catheter-based revascularization (such as PTCA) or surgical revascularization with coronary artery bypass surgery (CABG). The interventions will include medical anti-ischemic therapy targeted to relieve angina, aggressive medical anti-ischemic therapy targeted to alleviate all of ischemia, and revascularization. The primary endpoint is death from any cause and non-fatal myocardial infarction at 5 years.Recurrence of ischemia, functional status, quality of life, and health care costs related to the above strategies will also be assessed. The estimated sample size is 6,000 patients to be recruited from approximately 10 clinical network centers. The Clinical Data Coordinating Center (CDCC) for the SOCRATES trial will participate in and have the following responsibilities: 1) development, providing and maintaining a Manual of Operations at all sites and assume leadership in the protocol finalization; 2) development and standardization of quality data gathering forms for assessment of study endpoints; 3) development and providing procedures for data entry at each site participating in the recruitment of patients; 4) development and providing randomization scheme to all sites enrolling patients within the Clinical Network Centers (CNC) on 24 hours basis; 5) implementation and maintaining a Web site for the study; 5) monitoring patient recruitment and providing weekly reports; 6) development and providing a protocol for and implementing data collection standardization for all CNCs; 7) development and providing quality control measures and monitoring and preparing reports on status of performance of the CNCs; 8) establishment of separate core laboratories for analysis and interpretation of ambulatory ECG, and resting and exercise ECG data, and providing for central interpretation of angiographic data and quality of life and costs data on subsample of patients; 9) provide, implement and prepare a report on quality control measures and monitor status of performance of the core laboratories; 10) coordinate and arrange regular Steering Committee meetings and prepare and distribute the minutes; 11) monitor and report major adverse effects and 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; 12) provide a manual of operations for a morbidity and mortality classification committee (MMCC); and 13) analyze all data and prepare results of the study for publication. All above reports/documents should be also Web ready. Small business firms with demonstrated experience performing the tasks, described in items 1-13 above, in large clinical trials are invited to submit capability statements. The capability statements must provide evidence of experience in performing the responsibilities described in items 1-13 above and demonstrate the following: 1) the availability and professional qualifications of scientists and technical staff needed to perform the work, including expertise in clinical cardiology, cardiac surgery and coronary angioplasty, cardiovascular pharmacology, management of myocardial ischemia, congestive heart failure, ambulatory, rest and exercise ECG, cost and medical resource utilization, data collection, data monitoring, data analysis, quality control, management of side effects, and adverse reactions to drug therapy; 2) the organizational flexibility to quickly modify the labor mix to meet changing levels of demand; 3) the experience and expertize in both individuals and the organization in the operation of a Clinical Data Coordinating Center in coordinating, monitoring, and managing a clinical trial for cardiovascular disease similar in complexity and magnituted to the SOCRATES (6,000 participants to be recruited from 10 large clinical network centers, several core laboratories, and blinded placebo-controlled drug administration); 4) the evidence of ability to implement it in a standardized fashion in a study similar to SOCRATES, including accessing and overseeing 10 large clinical networks of investigators to enroll and follow 6,000 patients, including women and minorities, over a minimum of 4 years after enrollment, 5) evidence of prior experience in developing a suitable plan for the proposed methods of coordinating, monitoring, and central management of all activities required by the study protocol in a study similar to SOCRATES, 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, and the ability to provide real time communication and data collection; 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 or SIC 8733: Noncommercial Research Organizations. 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 Commerce Business Daily (CBD). Posted 08/11/98 (W-SN235665). (0223)

Loren Data Corp. http://www.ld.com (SYN# 0014 19980813\A-0014.SOL)