NIH GUIDE, Volume 22, Number 39, October 29, 1993




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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