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 CENTERS FOR PRELIMINARY STUDIES ON RETINOIC ACID TREATMENT IN EMPHYSEMA SOL NHLBI-HR-99-01 DUE 031599 POC Douglas W. Frye, 301-435-0340 E-MAIL: df23a@nih.gov, df23a@nih.gov. The overall objective of this Broad Agency Announcement research contract program is to conduct preliminary studies preparatory to conducting a randomized, controlled, clinical trial on the efficacy of retinoic acid therapy in the management of emphysema. Objectives are to identify optimal patient populations, drugs and dosing schedules, and outcome measures for a larger study, if indicated. It is expected that proposals submitted in response to this RFP for Clinical Centers will have varying technical approaches, but will have many measures and procedures in common. It is expected that this program will involve 4-5 Clinical Centers and a Data Coordinating Center. A separate request for proposals will be released for the Data Coordinating Center. Offerors will be expected to submit protocols that have been reviewed and approved by their Institutional Review Board. During Phase I (3 months), investigators will meet to discuss, critique, and assess the complementary aspects of their respective protocols,develop common definitions, standardize produres across centers, develop cooperatively common data reporting forms, and establish and train staff. During Phase II (up to 27 months), investigators will be expected to recruit, enroll, treat and follow patients according to their protocols. Investigators will collect and forward data to the Data Coordinating Center. During Phase III (6 months), investigators will interact with other study investigators in the preparation and writing of reports and manuscripts for publication and work with the Data Coordinating Center to provide data and related information necessary for data analysis. Offerors must include sample size justifications and plans for data collection, management and statistical analysis. A Data Coordinating Center will collect, verify, store and analyze data from the Clinical Centers and describe the progress of the study to the Steering Committee, Program Office and the Data and Safety Monitoring Board (DSMB). The Steering Committee will be composed of the Principal Investigator from each Clinical Center and the Data Coordinating Center and a representative from the Program Office. The Steering Committee will meet twice a year to review progress of the studies. An independent DSMB will be appointed by the NHLBI to oversee the safety of all research protocols. This is not an RFP. It is anticipated that RFP NHLBI-HR-99-01 will be available on or about December 1, 1999. The RFP will be available electronically. Access via the NHLBI Website(http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm). Correspondence should be directed to the Contractting Officer, Douglas W. Frye. E-mail address: df23a@nih.gov or telephone number 301-435-0340. Posted 11/02/98 (W-SN267268). (0306)

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