SOURCES SOUGHT
A -- Acute Respiratory Distress Syndrome Clinical Coordinating Center
- Notice Date
- 11/3/2003
- Notice Type
- Sources Sought
- 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
- 11/28/2003
- Archive Date
- 12/13/2003
- Point of Contact
- David Merrell, Contract Specialist, Phone (301) 435-0340, Fax (301) 480-3338, - Pamela Lew, Acting Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
dm416n@nih.gov, pl116x@nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) intends to establish a Clinical Network for the Development of Treatments for Acute Lung Injury and the Acute Respiratory Distress Syndrome (ALI/ARDS) which will consist of ten Clinical Care Treatment Groups (CCTGs), which may include international sites, and a Clinical Coordinating Center (CCC). The Network will develop and conduct randomized controlled clinical studies under multiple protocols for the prevention and treatment of ALI/ARDS. The CCTGs, consisting of one or more participating intensive care units, are expected to enroll a total of 300 subjects per year for five years. The NHLBI intends to release separate Request for Proposals (RFPs) for the CCTG and the CCC to coordinate all aspects of the research and to manage and analyze the patient and research data. The CCC will participate in a cooperative effort with the CCTGs and a representative of the NHLBI to form a Steering Committee that serves as the governing body of the Network. The Principal Investigator (PI) of each CCTG and the CCC will be voting members of the Steering Committee. The CCC will have a key role in study design, oversight and monitoring, data collection, data integrity, reporting and Network functioning. The CCC will prepare confidential reports and analyses for NHLBI review committees including a Protocol Review Committee (PRC) and a Data Safety and Monitoring Board (DSMB). Personnel should be knowledgeable and 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, and management of data collection tools and ensuring quality control. The CCC will include personnel experienced in pulmonary and critical care medicine. The CCC will develop plans for randomization of patients, data collection and analysis, monitoring of data, reporting of data to the DSMB, and analysis of manuscripts for peer review. 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 CCTG staff in implementing protocols and entering data. 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 monitor data for accuracy and completeness, and will establish a mechanism for on-site monitoring of patient records by a clinical nurse in order to validate data entry. The CCC will be responsible for maintaining confidentiality of data and for monitoring development of informed consent forms. The CCC will be responsible for coordinating communications among CCTGs and scheduling conference calls and meetings of study committees as needed. The CCC will also organize meetings of the DSMB and PRC, and prepare statistical reports and minutes of these meetings. The PI(s) of the CCC will attend DSMB meetings to present data. Data collection is expected to involve the most modern techniques available that can be supported in intensive care units. 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 bedside data collection systems. The data collected should be in a format that allows easy uploading of data from CCTGs to the CCC via the internet. The CCC should be familiar with automatic downloading of data from laboratory systems. Although not required at this time, the CCC will be required to develop an automated information systems security plan prior to contract award. This announcement is a market survey to assess the availability and technical capability of small businesses as defined by NAICS code 541710 for research and development in the physical, engineering, and life sciences. The appropriate size standard is 500 employees. Small business firms having demonstrated experience in meeting the requirements described above are invited to submit capability statements in original and two copies. Capability statements must provide evidence of 1) the availability of professional staff qualified in pulmonary and critical care medicine, statistics, and clinical nursing, 2) the experience of the organization to manage a program of this scope, 3) facilities for performance of the requirements listed above, and 4) the organization?s status as a small business under NAICS code 541710. Capability statements in response to this sources sought synopsis that do not provide sufficient information for evaluation will not be considered. This is not a request for proposals and responses should not include budgetary information. The RFP release date is anticipated on or about March 31, 2004. The Government intends to award one contract for a period of seven years, on or about September 1, 2005. Firms responding to this market survey must provide pertinent information to the requirements described above by November 28, 2003.
- Record
- SN00463694-W 20031105/031103213115 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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