SOLICITATION NOTICE
A -- Data Coordinating Center for Long-Term Oxygen Treatment Trial
- Notice Date
- 9/16/2005
- 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-06-08
- Response Due
- 9/26/2005
- Archive Date
- 9/30/2006
- Description
- RESEARCH AND DEVELOPMENT SOURCES SOUGHT: The NHLBI is seeking a small business with the ability to serve as a Data Coordinating Center (DCC) for a new five-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 (COPPED) and moderately severe hypoxemia. The ultimate goal of the NHLBI is to improve clinical management of COPPED, with increased length and quality of life for patients with COPPED. 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 solicited under a separate request for proposal. 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 Data and Safety Monitoring Board (DSMB); 5) prepare and distribute minutes of the Steering Committee 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 HCFA representative and the contracting officer, and 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. 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 the strong medical and scientific qualifications and experience relating to COPPED. The DCC?s medical monitor should be board-certified in pulmonary medicine, have expertise in the clinical management of COPPED, and experience in clinical research. The DCC must have experience with complex multi-center trials, readily available 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. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer at the above noted address. The capabilities statement submitted in response to this synopsis shall include 1) the total number of employees, 2) the professional qualifications of scientist, medical expert, and technical personnel in accordance with the above outline requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous multi-center research projects in which the small business organization and the proposed personnel have participated and any other information considered relevant to this program. The information provided must also establish the institution?s status as a small business. Three copies of the capabilities statement must be received at the address listed above twelve days from the publication date of this announcement. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. The RFP will be available in FedBizOpps and electronically via the NHLBI Website.
- Place of Performance
- Address: NA
- Record
- SN00897020-W 20050918/050916211740 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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