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 RFP NHLBI-HV-98-33 DUE 012199 POC William M. Stevens, Contracting Officer; (301) 435-0345, fax (301) 480-3430 WEB: http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm, http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. E-MAIL: ws69s@nih.gov, ws69s@nih.gov. The National Heart, Lung, and Blood Institute has a requirement for a Clinical Data Coordinating Center (CDCC) to conduct a multicenter randomized clinical trial, enrolling and following a total of 6,000 patients for a minimum of 4 years. The proposed contract is 100% set aside for small business. The SIC code as defined by Standard Industrial Code (SIC) 8731 (500 employees) or 8733 (5 Million dollars). The "SOCRATES" trial will assess the benefits and risks comparing three clinically employed strategies (two medical anti-ischemic strategies and early revascularization) with respect to long term morbidity and mortality. The trial results will provide a rational basis for safe and effective therapy for these types of patients with stable CHD, and will provide insights into the role of ischemia in the long-term clinical outcome of CHD patients. Furthermore, the results will be evaluated for significant health care cost implications. The study will enroll a total of 6,000 patients with stable coronary disease (CHD) (based on eligibility and exclusion criteria) in whom there is equipoise between medical therapy and revascularization (catheter-based or surgical). The choice between the potential revascularization approach that might be used, PTCA or CABG, will be made by physician and patient before randomization. The protocol, including study design, entry criteria, randomization procedures, and treatment strategies are provided in the RFP. Final drug regimens for medical strategies and analyses which will be incorporated into the protocol will be defined collaboratively during the implementation phase developed by a planning committee that will include the successful respondent to this RFP. The trial will address two key questions of therapeutic strategy in the management of coronary heart disease (CHD): first, in medical management, does anti-ischemic therapy escalated to a maximum tolerated regimen, targeted to alleviate all of the ischemia, confer long-term morbidity and mortality benefits beyond anti-ischemic therapy targeted just for relief of angina; and second, have advances in medical management of CHD (particularly aggressive lipid management, anti-thrombotic therapy, and life style risk factor modification) changed the threshold at which mechanical revascularization is warranted? These questions will be addressed in patients with stable 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). Functional status and health care costs related to the above strategies will also be assessed. 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 proceduresfor 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. The cost-reimbursement contract will be awarded for seven years. This is not the Request for Proposals (RFP). RFP No. NHLBI-HV-98-33 will be released on or about November 16, 1998 on the NHLBI contracts web page at http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm#rfp. There are no paper copies. Interested organizations should review and download the streamlined RFP designated as RFP # NHLBI-HV-98-33 which will appear under the list of RFPs for the National Heart, Lung, and Blood Institute. Further instructions and forms for proposal submission are located at the menu selection entitled "Streamlined RFP References" which is located at the web page for the NIH Request For Proposals Directory, URL:http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. This proposed program is for a set aside for small business vendors; the SIC Code is 8731 (500 employees) or 8733 (5 Million dollars). See numbered Note 1. Posted 10/27/98 (W-SN265710). (0300)

Loren Data Corp. http://www.ld.com (SYN# 0007 19981029\A-0007.SOL)