SOLICITATION NOTICE
A -- Long-term Oxygen Treatment Trial (LOTT): Data Coordinating Center (DCC)
- Notice Date
- 11/9/2005
- 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, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HR-06-08
- Archive Date
- 9/30/2006
- Point of Contact
- Joanne Deshler, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338, - Pamela Lew, Chief, HLVD Branch, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
jd52g@nih.gov, pl116x@nih.gov
- Description
- The NHLBI is seeking a Data Coordinating Center (DCC) for a new six-year multi-center clinical trial, Long-Term Oxygen Treatment Trial (LOTT). The Long-Term Oxygen Treatment Trial (LOTT) is 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. It is estimated that data will be collected from approximately 5,000 subjects and that it will include demographics, medical history, medications, results of clinical laboratory tests, and responses to questionnaires. Approximately 250 subjects will be enrolled over a 30 month period at each of approximately 20 Regional Clinical Centers (RCCs) solicited under RFP NHLBI-HR-06-07. Subjects will be followed for up to 42 months. One or more substudies that enhance the scientific value of the parent trial will also be performed in this program. Substudies may be conducted at all RCCs or at only a subset of the RCCs. Substudies will be selected and designed by the Substudy Subcommittee of the Steering Committee. The DCC will: 1) provide biostatistical support for protocol development, including power and sample size calculations and simulations; for study monitoring; and for the analysis of study data; 2) administrative guidance, oversight, and support for the LOTT as a whole; promoting interactions among the RCCs and assuring uniformity of study activities at all sites; 3) make travel arrangements and reimbursement to the Steering Committee chair; 4) make travel arrangements and reimbursement to the Data and Safety Monitoring Board (DSMB) members; 4) coordinate, plan, make arrangements for, and participate in the meetings of the Steering Committee and its subcommittees and of the DSMB; 5) prepare and distribute minutes of the Steering Committee and DSMB meetings; 6) establish and maintain a computer system and software needed for the storage and analysis of study data; 7) develop and maintain a study web site for the distribution of LOTT information, documents, and forms to the RCCs, 8) develop and maintain a public web site that provides information about the LOTT for the lay public; 9) prepare and distribute periodic technical and statistical reports to the participating RCCs, the project officer, a Centers for Medicare and Medicaid Services (CMS) representative and the contracting officer, 10) review, at least weekly, study plans, procedures, activities, and data to ensure the scientific validity and clinical relevance of the trial and the protection of human subject safety and privacy, and 11) monitor adverse event reports for patterns of safety or toxicity that may warrant changes in the study. The DCC will frequently need to make quick decisions, often based on medical information obtained from the clinics. Therefore, staff will need to possess strong medical and scientific qualifications and experience relating to COPD. The DCC’s medical monitor should be board-certified in pulmonary medicine, have expertise in the clinical management of COPD, and experience in clinical research. The DCC must have experience with complex multi-center trials, readily available pulmonary medical expertise, and the ability to analyze a large volume of physiologic, quality of life, medical morbidity and mortality data. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFPs will be available on or about November 25, 2005 at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on FedBizOpps. 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 WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (09-NOV-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS 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-06-08/listing.html)
- Record
- SN00930144-F 20051111/051109214059 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |