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

A -- CHELATION THERAPY OF ANGINA PECTORIS SOL NIH-NHLBI-HC-00-05 POC Eve A. Schaefer, (301) 402-3670 or (301) 435-0345 E-MAIL: Eve A. Schaefer, es204n@nih.gov. The National Heart, Lung, and Blood Institute is conducting a market survey to assess the availability and technical ability of small business firms to perform as the Coordinating Center in the conduct of a clinical trial to determine whether EDTA chelation therapy reduces a combined end point of death, myocardial infarction, hospitalization for unstable angina, or revascularization in patients with chronic stable angina. Secondary objectives include assessment of death, exercise duration, and adverse effects. The study will be a multi-center, randomized, double-blind, placebo-controlled trial. The projected length of patient follow-up is three years after recruitment and completion of intravenous therapy. Eligible patients with chronic stable angina with a prior arteriogram showing obstruction of at least one major epicardial vessel and/or electrocardiographic evidence of prior myocardial infarction (q waves) will be enrolled. A baseline exercise tolerance test will be performed. Additional assessments will include radionuclide measurement of LV ejection fraction (LVEF) and clinical chemistry. Chelation therapy will be administered intravenously for 30 sessions during a period of 15 weeks. Thereafter, patients will be monitored for three years with assessment of exercise duration at one year, and annual assessment of clinical chemistry and changes in cardiovascular drug therapy. The trial shall be conducted in three phases: I) Development of Protocol and Manual of Operations, Pilot Testing and Training (six months); II) Recruitment and Follow-up (two years); III) Follow-up (three years) and IV) Close-out and Analysis (six months). Specific tasks include: 1. Draft and finalize the Protocol and Manual of Operations to include collaboration with clinical sites, a central Pharmacy Distribution Center. 2. Implement a plan for randomizing approximately 2,000 patients into the study, by identifying all clinical sites on a rapid basis. 3. Implement a plan to ensure standardized quality data gathering and management for assessment of study outcomes. This plan should include data collection forms, a distributed data entry system for use at clinical sites, procedures for data transmission, and provisions for training appropriate clinic staff in data collection, entry, and transmission. 4. Establish and conduct timely reviews to classify all clinical outcome events in a uniform fashion with the reports available to the Data Safety and Monitoring Board (DSMB) and the Project Office. 5. Implement a plan for timely monitoring of adverse effects to maximize patient safety. 6. Monitor patient recruitment by providing weekly reports to the Project Office during the recruitment phases, and maintain updated reports on an Internet site accessible to all units of the study. 7. Maintain the study data base, including documentation of variables and maintenance of appropriate confidentiality and security of these files. 8. Analyze and present data collected during the course of the study. 9. Maintain quality control (QC) at, andmonitor the performance status of the clinical sites. 10. Solicit, select, and oversee the Pharmacy Distribution Center, whose function is to distribute all study kits to the clinical sites in a timely and efficient manner. 11. Coordinate, participate in, and provide any information necessary for regular Steering Committee meetings, and prepare and distribute minutes of each meeting and any other correspondence necessary. Coordinate and provide any information for conference calls with the clinical sites and investigators. 12. Assume responsibility for arranging and conducting regular DSMB activities. 13. Prepare annual reports, a final report, and other reports as required. 14. Implement a plan for final data collection, pooling, and verification, and for analysis of all data from all clinical sites. 15. Analyze data as needed for study publications. Prepare study publications in collaboration with other study investigators and the Project Office. 16. Provide a final study dataset with documentation. Small business firms having demonstrated experience in performing the same or similar requirements are invited to submit tailored capability statements which will be considered based on the following criteria: 1) Firms must demonstrate specific competence and prior experience of professional, technical, and administrative staff pertinent to the operation of a Coordinating Center in multi-center, randomized clinical trials related to cardiovascular disease with clinical outcomes; 2) Firms must demonstrate on-site medical and scientific expertise in cardiovascular medicine and therapy, management of side effects and adverse reactions to proposed therapies, database management, and statistical methods and data analysis. Senior staff include a project director (principal investigator), physician, statistician, and computer programmer. Other staff include data entry personnel (web-based applications) and administrative support; 3) Firms must demonstrate knowledge and understanding of scientific issues related to therationale and design of the trial, including the importance of the research question, knowledge of cardiovascular disease, and understanding of trial design and state-of-the-art analysis methods; 4) Firms must demonstrate adequate organizational and administrative structure to perform as a Coordinating Center in a multi-center, long-term cardiovascular clinical trial including prior successful participation of the firm in such, both in central data management and coordination of protocol-mandated activities; 5) Firms must demonstrate adequate organizational commitment to the program as well as adequate facilities, equipment, and space for accomplishing the work. Firms must indicate small business status under SIC Code 8099, with a size standard of $5 million. The intended procurement is a new requirement. The Government intends to negotiate one contract for a period of six years. This is not a Request for Proposals (RFP) and responses to this announcement should not include budgetary information. Firms responding to this market survey should provide pertinent capability information in response to the requirements outlined above (in an original and five copies) within 15 calendar days from the date of publication of this announcement. Posted 01/19/00 (W-SN417043). (0019)

Loren Data Corp. http://www.ld.com (SYN# 0010 20000121\A-0010.SOL)