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 COORDINATING CENTER FOR FEASIBILITY STUDIES ON RETINOID TREATMENT IN EMPHYSEMA SOL NHLBI-HR-99-02 DUE 032299 POC Joanne C. Deshler, 301-435-0340 E-MAIL: jd52g@nih.gov, jd52g@nih.gov. SIC 7379. The overall objective of this research contract program is to conduct feasibility studies at 4-5 clinical centers on the use of retinoids in the treatment of emphysema. The specific objectives of the program are to identify optimal patient populations, retinoids, doses, dosing schedules, routes of administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema, should such a study be indicated. This program will be conducted in three phases. During Phase I (6 Months), investigators will meet to discuss, critique, and assess the complementary aspects of their respective protocols, develop common definitions, standardize common procedures across centers, develop cooperatively common data reporting formats, and establish and train staff. During Phase II (up to 24 Months), each investigator will be expected to recruit, enroll, treat, and follow emphysema patients according to their protocol. Investigators will collect and forward data to the Clinical Coordinating Center (CCC). During Phase III (6 Months), investigators will interact with other study investigators and the Project Office in the preparation and writing of reports and manuscripts for publication and work with the CCC to provide data and related information necessary for data analysis. A clinical center awarded a contract (RFP NHLBI-HR-99-01) will execute its protocol according to the technical approach it has proposed, though clinical center contractors shall work collaboratively during Phase I to refine complementary aspects of their respective protocols, develop common definitions, consider common outcomes, standardize common procedures across centers, develop cooperatively common data reporting formats, and generally work so that the different studies are comparable and complementary. The CCC will be responsible for 1) assuming leadership in areas of statistical analyses, including sample size determinations, for each study and across studies; 2) participating in a cooperative effort with the other investigators in the formation of a Steering Committee, development of comparable and complementary protocols, development and testing of compatible reporting forms for each study, and development of the manual of operations; 3) preparing the agendas for, coordinating, and managing the meetings and calls of the Steering Committee, its subcommittees, and the Data and Safety Monitoring Board; 4) preparing and distributing minutes of Steering Committee meetings; 5) standardizing, printing, and distributing reporting forms, the study protocols, and manual of operations; 7) developing and establishing methods for data entry, data collection, and data transmission and training clinical center staff in these methods; 7) receiving, collecting, processing, storing, and analyzing data collected from the clinical centers; 8) assuring that data are forwarded in accordance with an established time schedule and are reviewed for accuracy and completeness; 9)assuring that quality control is maintained during the collection and processing of all measurments; and 10) describing the progress of the program and program results to the Steering Committee, Program Office, and the Data and Safety Monitoring Board; 11) preparing and distributing periodic technical and statistical reports, and 12) cooperating in the reporting of the data results. The proposed staff of the CCC must have demonstrated experience in conducting multi-center trials, in working with clinical investigators from multiple sites, in the development of study protocols and Manual of Operations, in the monitoring the clinical centers to ensure that data are reviewed for completeness and that quality control is maintained prior to processing, and in conducting proper statistical analyses of the data. The staff must have appropriate biostatistical and statistical experience relevant to multi-center clinical research studies. Meta-analysis methodology may be necessary to analyze data across studies. The Principal Investigator must have demonstrated leadership experience in large data management systems, in protocol development for large multicenter studies, and interaction with clinical center investigators from multiple sites. The CCC must have regular commitment of a physician(s) with strong medical and scientific knowledge and experience in care and treatment of patients with emphysema. The Steering Committee will be composed of the principal investigator from each site, the clinical coordinating center and representatives from the NHLBI. The Steering Committee will meet three times in Phase I, twice a year in Phase II, and twice in Phase III. An independent Data and Safety Monitoring Board appointed by the NHLBI will oversee the safety of all research protocols. This is not an RFP. It is anticipated that RFP NHLBI-HR-99-02 will be available on or about January 23, 1998, with proposals due on or about March 15, 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 Contracting Officer, Ms Joanne Deshler. E-mail address: jd52g@nih.gov or telephone number (301) 435-0340. Posted 01/08/99 (W-SN286436). (0008)

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