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

A -- MEDICAL COORDINATING CENTER FOR PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL SOL NIH-NHLBI-HB-00-02 POC Joanna Magginas, Contracting Officer, (301)435-0360 E-MAIL: Joanna Magginas, Contracting Officer, jm112c@nih.gov. The objective of this clinical trial is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia. This trial will involve: a) approximately ten clinical centers with expertise in treating pediatric sickle cell anemia; b) a medical coordinating center (MCC); c) a pharmacy distribution center; d) a blood and chemistry laboratory; and e) a cytogenetics laboratory. It is anticipated that 200 children between the ages of 6 months and 24 months of age with sickle cell anemia will be followed at the clinical sites. Responsibilities for the MCC include, but are not limited to, the following: 1) solicit, select and oversee a pharmacy distribution center, a blood and chemistry laboratory, and a cytogenetics laboratory; 2) identify medical consultants who will serve as the Endpoint Adjudication Panel; 3) coordinate the development, production, and distribution of the study protocol, study forms and the manual of operations and arrange, manage and provide minutes for meetings of the Steering Committee, Data Safety and Monitoring Board, and subcommittees, if any; 4) develop a system for random assignment to each treatment arm for each patient enrolled in the trial; 5) prepare statistical reports as needed to monitor study progress, quality of data, participating center performance, etc.; 6) assure the quality of data submitted and stored; 7) conduct site visits; 8) track patient blood samples sent by clinical centers to the blood and chemistry laboratory; 9) provide data management and analytical services for approved ancillary studies; 10) participate in the analysis and writing of trial manuscripts and reports for publication and presentation. The proposed procurement is under a 100 percent small business set-aside, the size standard for which is defined by Standard Industrial Classification (SIC) Code 8731. It is anticipated that one six-year cost reimbursement type contract will be awarded on or about June 1, 2000. This is not a Request for Proposals. RFP NHLBI-HB-00-02 will be available on or about June 30, 1999 and may be accessed at the following URL location: http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm. No paper copies will be available. Posted 06/15/99 (W-SN343185). (0166)

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