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

A -- CLINICAL DATA COORDINATING CENTER FOR PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL (PED HUIII) SOL NHLBI-HB-99-09 DUE 122198 POC Joann Ciufolo, Contracting Officer, 301-435-0359 WEB: NA, NA. E-MAIL: NA, ciufoloj@nih.gov. The Blood Diseases and Resources Program of the National Heart, Lung, & Blood Institute (NHLBI) 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 the Clinical Data Coordinating Center (CDCC) for the Pediatric Hydroxyurea Phase III Clinical Trial (PED HUIII). The objective of this double-blinded, placebo-controlled trial is to test the hypothesis that Hydroxyurea therapy is effective in the prevention of chronic organ damage in pediatric patients with sickle cell anemia (HbSS). Study design will test the efficacy of hydroxyurea in preventing the onset of organ damage in very young children recruited between 6 and 24 months of age. Approximately 200 children will be evaluated annually for changes in brain function, pulmonary function, renal function, growth and development milestones, and quality of life. The study will involve 100 children with HbSS in each study arm to receive either hydroxyurea or placebo. The CDCC will have oversight of approximately 10 pediatric clinical centers, a clinical pharmacy/drug distribution center, and a central blood laboratory. The CDCC for the PED HUIII Clinical Trial will participate in and have the following responsibilities: 1) development of plan for initial assessment, subsequent follow-up of patients, and retention of the pediatric hydroxyurea phase III clinical trial patients; 2) developing, providing and maintaining a manual of operations at all sites and assume leadership in the protocol finalization; 3) development of software and data collection format for use by participating clinical centers; 4) implementation of a database management system; 5) oversight of standardized data collection for all clinical centers; 6) perform data analysis and assurance of quality control; 7) establishment of a separate central blood laboratory; 8) establishment of a clinical pharmacy/drug distribution center; 9) coordinate and arrange regular Steering Committee meetings and prepare and distribute minutes; 10) monitor and report major adverse effects and prepare clinical, technical, and statistical report in the form needed by a Data and Safety Monitoring Board to evaluate the safety of the protocol to patients; and 11) participate in the preparation of study results for publication. Small business firms having demonstrated experience in performing the tasks listed in 1-11 above, in large clinical trials are invited to submit capability statements (original and two copies). Capability statements must provide evidence of experience in performing the responsibilities described in items 1-11 above and demonstrate the following: 1) the availability and professional qualifications of scientists and technical staff needed to perform the work, including expertise in sickle cell disease, data collection, data monitoring, data analysis, quality control, 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 expertise in both individuals and the organization in the operation of a Clinical Data Coordinating Center in coordinating, monitoring, and managing a similar clinical trial (200 patients to be recruited from 10 pediatric centers, core laboratories, and double-blinded placebo-controlled drug administration); 4) 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 similar study, including procedures, randomization of patients, coordinating of data collection, and specialized tests; 5) experience in analysis and interpretation of medical data for purposes of ensuring patient safety; 6) ability to implement a study in a standardized fashion; 7) facilities and resources necessary for the performance of the requirements listed above; and 8) the firm's status as a small business under Standard Industrial Code 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), and responses should not include budgetary information. The RFP release date is pending. The government intends to negotiate one contract for the period of six years, with approximate date of award September 29, 1999. Firms responding to this market survey should provide pertinent information to the requirements mentioned above within fifteen (15) calendar days from the date of publication of this announcement in the Commerce Business Daily (CBD). Posted 12/04/98 (W-SN277428). (0338)

Loren Data Corp. http://www.ld.com (SYN# 0007 19981208\A-0007.SOL)