CLINICAL COORDINATING CENTER FOR A CLINICAL NETWORK FOR THE TREATMENTOF THE ADULT RESPIRATORY DISTRESS SYNDROME NIH GUIDE, Volume 22, Number 39, October 29, 1993 RFP AVAILABLE: NHLBI-HR-94-04 P.T. Keywords: National Heart, Lung, and Blood Institute The purpose of this seven-year program is to establish an infrastructure to support ongoing clinical studies of adult patients with Adult Respiratory Distress Syndrome (ARDS) and those at risk of developing ARDS. The Network will consist of up to ten Critical Care Treatment Groups (CCTGs) a Clinical Coordinating Center (CCC) and representation from the National Heart, Lung, and Blood Institute (NHLBI). Study protocols will be developed and prioritized by a Steering Committee composed of the Principal Investigators (PI) of the CCTGs, the PI of the CCC, and the NHLBI Project Officer. The program will be performed in three phases. Phase I will be 12 months and will involve the development of protocols and the manual of operations. Phase II will be 60 months and will involve enrollment of patients into protocols, continued development of new protocols, and analysis of data produced by the first protocol studies. Phase III will be a 12 month effort to complete all follow up, data analysis, and preparation of publications. While the exact number and type of patients to be studied (i.e., patients with ARDS or patients at risk of developing ARDS) will depend on the protocols that are chosen by the Steering Committee, it is estimated that each CCTG will be capable of enrolling 40 patients each year into protocols. It is anticipated that observational studies may be undertaken. The CCC will be responsible for (1) contributing substantially to protocol development; (2) designing the system for collection, entry, and management of data with feedback systems for quality control; (3) coordinating the development, printing, and distribution of the study protocols, reporting forms, and manual of operations; (4) directing all aspects of data analysis including the development of methods of data analysis and computer software to accomplish all of the above listed functions; (5) preparing and distributing technical and statistical reports as required; (6) coordinating and managing meetings of the Steering Committee and Data and Safety Monitoring Board; (7) monitoring patient eligibility; and (8) monitoring untoward drug effects. This program will involve the performance of research activities involving therapy of critically ill patients and will require interaction on a daily basis with the CCTGs regarding clinical and safety issues. This announcement is for a clinical coordinating center only. A separate Request for Proposals (RFP) for the clinical care treatment groups (CCTGs) has been released. This is not an RFP. It is anticipated that RFP NHLBI-HR-94-04 will be available on or about October 20, 1993, with proposals due January 27, 1994. It should be noted that award of a contract for this study will be made only to offerors who are located in the United States of America or Canada. Copies of the RFP may be obtained by submitting a written request and three self-addressed mailing labels to: Pamela S. Randall Contracts Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 654 Bethesda, MD 20892 .
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