SOLICITATION NOTICE
A -- Long-Term Oxygen Treatment Trial (LOTT), Regional Clinical Centers
- Notice Date
- 10/24/2005
- 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
- NHLBI-HR-06-07
- Response Due
- 1/31/2006
- Point of Contact
- Joanne Deshler, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338, - Pamela Lew, Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
jd52g@nih.gov, pl116x@nih.gov
- Description
- The Long-Term Oxygen Treatment Trial (LOTT) contractors will design and conduct a randomized controlled clinical trial to assess the efficacy of around-the-clock, supplemental oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) and moderately severe hypoxemia. This trial is needed to provide a scientific basis for decisions regarding the clinical use of long-term oxygen treatment. The ultimate goal of this project is to improve clinical management of COPD, with increased length and quality of life for patients with COPD. The LOTT will consist of one DCC and approximately 20 regional clinical centers (RCCs). The RCCs will be awarded under RFP NHLBI-HR-06-07 and the DCC will be awarded under RFP NHLBI-HR-06-08. The LOTT will test the efficacy of supplemental oxygen treatment in subjects with COPD, moderately severe hypoxemia, and other risk factors for premature death such as severe dyspnea, exercise limitation, low body mass, or frequent exacerbations. The trial will be designed to detect a difference in mortality between two groups randomized to receive long-term oxygen treatment or usual care with periodic monitoring of hypoxemic status. The trial will also test for possible differences in quality of life. Contractors will design and carry out the clinical trial, monitor and report adverse events, analyze the study data, submit results of the study and substudies for publication in peer-reviewed scientific journals, and engage in other dissemination activities. Each RCC will organize and manage a network of cooperating sites (such as hospitals, clinics, pulmonary rehabilitation centers, and physician offices) to assist in subject enrollment, characterization, and follow up. It is expected that a total of approximately 5000 subjects will be enrolled over a 3 - 3½ year period and that subjects will be followed for an additional year after the end of the enrollment period. The trial will be conducted in three phases. During Phase I (6 months) investigators will meet to develop the Protocol(s), model informed consent document(s), Manual of Operations, and study forms. The Steering Committee will develop procedures and tools for training of staff, randomization of subjects, data management, and quality assurance/quality control of study activities and data. Staff will assist the DCC in the development of study forms. During Phase II (4 years 6 months) staff will be trained, subjects screening and recruited, interventions, and follow-up will be performed at the RCCs and data collection and monitoring will occur at the DCC. During Phase III investigators will engage in dissemination activities which include data analysis and reporting. This announcement is not a request for proposals (RFP). It is anticipated that the RFPs will be available on or about November 8, 2005 at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on FedBizOpps at: http://www.fedbizopps.gov. This advertisement does not commit the Government to award a contract. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541710. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (24-OCT-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 15-AUG-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HR-06-07/listing.html)
- Record
- SN01116154-F 20060817/060815223449 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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