SOLICITATION NOTICE
A -- CLINICAL CENTERS FOR A CLINICAL RESEARCH NETWORK FOR THE TREATMENT OF ACUTE LUNG INJURY AND ACUTE RESPIRATORY DISTRESS SYNDROME
- Notice Date
- 5/25/2004
- 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-05-04
- 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, - Pamela Lew, Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
dm416n@nih.gov, pl116x@nih.gov
- Description
- CLINICAL CENTERS FOR A CLINICAL RESEARCH NETWORK FOR THE TREATMENT OF ACUTE LUNG INJURY AND ACUTE RESPIRATORY DISTRESS SYNDROME 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 10, 2004. NHLBI will release a separate Request for Proposal (RFP) for the Clinical Coordinating Center (CCC) as RFP-NHLBI-HR-05-05, on or about June 1, 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 CCC, 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 five and one-half 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 CCC. The Government intends to award ten contracts for a period of seven years, on or about September 1, 2005.
- Record
- SN00591921-W 20040527/040525211845 (fbodaily.com)
- Source
-
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