NIH GUIDE, Volume 22, Number 38, October 22, 1993


P.T. 34


  Pulmonary Diseases 

  Clinical Medicine, General 

  Clinical Trial 

  Treatment, Medical+ 

National Heart, Lung, and Blood Institute

The purpose of this program is to establish a network of up to ten

interactive critical care treatment groups (CCTGs) and a clinical

coordinating center (CCC) to rapidly assess novel treatment methods

in patients with adult respiratory distress syndrome (ARDS).  This

program is intended to provide a mechanism to establish and maintain

the required infrastructure to perform multiple therapeutic trials

that may involve investigational drugs, approved agents not currently

used for treatment of ARDS, or treatments currently used but whose

efficacy has not been well documented.  The CCTGs will be responsible

for:  (1) participating in the planning and development of the

network infrastructure and committee structure and in the development

and prioritization of multiple protocols, development of a manual of

operations and reporting forms; (2) training staff to conduct the

study as outlined in approved study protocols and manual of

operations; (3) enrolling and treating adult patients (with a gender

and racial composition representative of the local population) with

ARDS or a condition that predisposes to ARDS according to the

established study protocols; (4) performing follow-up assessment on

the subjects in the manner specified in the approved manual of

operations; (5) collecting and forwarding subject data to the CCC;

(6) interacting with the CCC to provide data and information

necessary for data analysis; and (7) participating with other study

investigators in the preparation and writing of reports and

manuscripts for publication.

This announcement is for clinical centers only, with up to ten awards

anticipated.  A separate Request for Proposal (RFP) for a Clinical

Coordinating Center will be released in the future.

This announcement is not an RFP.  It is anticipated that RFP

NHLBI-HR-94-05 will be available on or about October 20, 1993, with

proposals due on January 28, 1994.  It should be noted that award of

contracts for this study will be made only to offerors who are

located in the United States of America and Canada.  Copies of the

RFP may be obtained by submitting a written request along with three

self-addressed mailing labels to:

Pamela S. Randall

Contracts Operations Branch, DEA

National Heart, Lung and Blood Institute

Westwood Building, Room 654

Bethesda, MD  20892


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