ANNOUNCEMENT OF AVAILABILITY: CLINICAL CENTERS FOR A CLINICAL RESEARCH NETWORK
FOR THE TREATMENT OF ACUTE LUNG INJURY AND ACUTE RESPIRATORY DISTRESS SYNDROME

PRESOLICITATION NOTICE FOR RFP-NHLBI-HR-05-04

RELEASE DATE:  June 18, 2004

NOTICE:  NOT-HL-04-116

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)

This is not a request for proposals.  It is anticipated that RFP-NHLBI-HR-05-04 
for ten Clinical Centers (CCs) for the National Heart, Lung, and Blood Institute 
(NHLBI) Clinical Research Network for the Treatment of Acute Lung Injury (ALI) and 
the Acute Respiratory Distress Syndrome (ARDS) will be available at: 
http://www.nhlbi.nih.gov/funding/index.htm  on or about June 30, 2004.  NHLBI will 
release a separate Request for Proposal (RFP) for the Clinical Coordinating Center 
as RFP-NHLBI-HR-05-05, on or about June 21, 2004. The Network will develop and 
conduct randomized controlled clinical trials under multiple protocols for the 
prevention and treatment of ALI/ARDS. The ARDSNet will function with a Steering 
Committee (SC) of principal investigators from the CCs and the Clinical 
Coordinating Center, and a representative of the NHLBI. The SC will 
collaboratively develop, prioritize, and conduct the clinical trials.  The CCs, 
each consisting of one or more participating Intensive Care Units (ICUs), will 
enroll a total of 1650 subjects over 52 years of a seven-year project.  The actual 
number of clinical trials will depend upon availability of funds.  Initial Network 
protocol(s) may be selected from among those proposed by offerors that 
successfully compete as a CC.  Patient enrollment will consist of appropriate 
gender and minority representation.  It is recognized that offerors will be 
limited by the patient population that is admitted in intensive care units, which 
is determined by the demographics of the local population.  Offerors must address 
in detail the gender and racial characteristics of their patient population.  
Funding decisions may be made with the objective of obtaining a trial-wide patient 
mix which includes 51% women and 25% minorities. To achieve enrollment of 30 
patients per year, offerors may involve affiliated institutions or hospitals, 
and/or enter into formal agreements with other institutions.  If necessary, 
collaborations within a local geographic area are encouraged to facilitate 
communication and oversight by the PI.  CC staff will be expected to participate 
in one or more of a number of subcommittees (e.g., publications, ethics, 
pathology, natural history, and progress assessment) which will hold meetings and 
teleconferences on an as-needed basis.  CC investigators will attend SC meetings 
approximately semiannually and participate in teleconferences monthly to discuss 
progress of the trials, identify concerns about the protocols and/or conduct of 
the trials, and determine whether changes to the protocols and other trial forms 
are necessary.  The PI will be responsible for overseeing the quality of patient 
screening, enrollment, and care, and for achieving a minimum enrollment of 30 
ALI/ARDS patients per year.  The PI will have responsibility for maintaining 
regular communications within his/her CC.  The PI and co-PI will be expected to 
make intellectual contributions to the development, conduct, and monitoring of 
trials.  CC personnel will be expected to participate in the development of 
appropriate and feasible sub-studies.  The project will conclude activities with 
the submission of final abstracts and manuscripts for publication and 
presentation, and completion of final limited access data sets by the Clinical 
Coordinating Center. The Government intends to award ten contracts for a period of 
seven years, on or about September 1, 2005.

Points of Contact:

David Merrell, Contract Specialist, Phone (301) 435-0340, Fax (301) 480-3338, E-
mail: dm416n@nih.gov, and Pamela Lew, Chief HLV Contracts Section, Phone (301) 
435-0340, Fax (301) 480-3338, E-mail: pl116x@nih.gov.

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