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

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

RELEASE DATE:  June 18, 2004

NOTICE:  NOT-HL-04-117

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-05-05 
for a Clinical Coordinating Center (CCC) will be available at: 
http://www.nhlbi.nih.gov/funding/index.htm  on or about June 21, 2004.

The National Heart, Lung, and Blood Institute (NHLBI) intends to establish a 
Clinical Network of ten clinical centers and a CCC for the research of treatments 
for acute lung injury and the acute respiratory distress syndrome (ALI/ARDS).  
NHLBI will release a separate Request for Proposal (RFP) for the clinical centers 
as RFP-NHLBI-HR-05-04, on or about June 30, 2004.  The Network will develop and 
conduct randomized controlled clinical trials under multiple protocols for the 
prevention and treatment of ALI/ARDS.  The CCC will be responsible for 
coordination of all aspects of the ARDSNet, including development of standard 
operating procedures, coordination of all ARDSNet meetings and committees and 
development of public and private web sites.  The CCC will have primary 
responsibility for the statistical design and analysis of trials, and for 
development and conduct of procedures for efficient, confidential automated data 
collection, entry, and sharing.  Data collected will be in a format that allows 
easy uploading of data from the clinical centers to the CCC via internet if 
possible.  The CCC will assist in the preparation of reports and manuscripts for 
publication of trial results. The ARDSNet will function with a Steering Committee 
(SC) of principal investigators from the clinical centers and the CCC, and a  
representative of the NHLBI.  The SC will collaboratively develop, prioritize, and 
conduct the clinical trials.  Protocols developed by the ARDSNet will be reviewed 
by an independent Protocol Review Committee (PRC) chosen by and reporting to the 
NHLBI.  Conduct of the trials will be monitored by an independent Data and Safety 
Monitoring Board (DSMB) chosen by and reporting to the NHLBI.  The clinical 
centers, each consisting of one or more participating ICUs, will enroll a total of 
1650 subjects over five and one-half years of a seven-year project.  The CCC will 
be responsible for the preparation and presentation of protocols to the PRC and 
interim data reports to the DSMB.  Personnel should be experienced in 
biostatistics and the conduct of clinical trials in critically ill patients. The 
PI(s) of the CCC will provide leadership in statistical issues including the 
design of study protocols and analysis of study data.  The CCC will be responsible 
for the design or selection, pre-testing and management of data collection tools, 
and ensuring confidentiality and quality control of data.  The CCC will coordinate 
pre-testing of data collection systems and have responsibility for reproduction 
and dissemination of protocols, manuals, and forms.  It will also coordinate 
training of CCC and clinical center staff in implementing protocols and entering 
data. Data collection is expected to involve the most modern techniques available 
that can be supported in intensive care units, in a format easily uploaded from 
the clinical centers to the CCC via the internet.  A central data collection 
system that allows periodic download of data from remote sites is preferred.  The 
CCC will need personnel knowledgeable in the design and uses of decision support 
tools, and familiar with both bedside data collection systems and automatic 
downloading of data from laboratory systems.  Although not required as part of a 
proposal, the CCC will be required to develop and submit an automated information 
systems security plan prior to contract award.  The CCC will develop plans for 
randomization of patients, reporting of data to the DSMB, and analysis of data for 
preparing manuscripts for peer review.  The CCC should be experienced in dealing 
with the Food and Drug Administration in obtaining approvals for new drugs and/or 
devices.  The CCC will be responsible for arranging for drug blinding and drug 
distribution as necessary.  The CCC will coordinate on-site reviews of patient 
records by a clinical nurse to validate the accuracy of data transmitted to the 
CCC.  The CCC will be responsible for monitoring development of informed consent 
statements.  The CCC will coordinate communications among clinical centers and 
schedule conference calls and meetings of study committees as needed. The CCC will 
also organize meetings of the PRC and DSMB, and prepare statistical reports and 
minutes of these meetings. The PI(s) of the CCC will attend DSMB meetings to 
present data.  The Government intends to award one contract 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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