SOLICITATION NOTICE
A -- Clinical Coordinating Center for a Clinical Research Network for the Treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome
- Notice Date
- 4/29/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- RFP-NHLBI-HR-05-05
- Response Due
- 9/17/2004
- Archive Date
- 10/2/2004
- Point of Contact
- David Merrell, Contract Specialist, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
dm416n@nih.gov
- Description
- 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 May 14, 2004. The National Heart, Lung, and Blood Institute (NHLBI) intends to establish a Clinical Network of ten clinical centers (CCs) and a CCC for the research of treatments for acute lung injury and the acute respiratory distress syndrome (ALI/ARDS). NHLBI will release separate Request for Proposals (RFPs) for the CCs and the CCC. 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 CCs 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 CCs 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 CCs, 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 CC 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 CCs 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 CCs 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.
- Record
- SN00576656-W 20040501/040429211815 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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