SOLICITATION NOTICE
R -- PLCO Special Projects
- Notice Date
- 8/23/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-50145-NV
- Response Due
- 9/7/2005
- Archive Date
- 9/22/2005
- Description
- In accordance with simplified acquisition procedures The National Cancer Institute (NCI), Division of Cancer Prevention (DCP), Early Detection Research Group (EDRG) proposes to acquire, on a sole source basis, the continued consulting services of Dr. Anthony B. Miller, Box 992, Niagara on the Lake, Ontario, Canada, for a one year base period with one, one year option period. The Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial is a large-scale, randomized study to determine whether certain screening tests will reduce the number of deaths from these cancers. For prostate cancer, men have a digital rectal exam and a blood test for prostate-specific antigen (PSA). For lung cancer, men and women receive a chest x-ray. For colorectal cancer, men and women are screened with flexible sigmoidoscopy. For ovarian cancer, women have a blood test for the tumor marker known as CA-125, and transnational ultrasound. Together, prostate, lung, colorectal, and ovarian cancers account for 48% of all cancers diagnosed and 49% of all cancer deaths in the United States each year. The tests being studied may detect these cancers before symptoms develop, but whether treatment at this stage will reduce the chance of dying from the diseases is unknown. Without a prospective randomized trial, it is difficult to determine to what extent an observed increase in survival with screening is a true benefit of early treatment, and to what extent it is an artificial effect (lead-time bias) of the extended interval between diagnosis and death introduced by screening. Uncertainty regarding the value of screening for the four PLCO cancers has resulted in conflicting positions in the medical community and confusion in the populations at risk. Because of the substantial infrastructure cost and effort required to mount a large-scale cancer screening trial, NCI determined that it would be most efficient and cost-effective to evaluate screening for all four PLCO cancers in a single trial. The contractor shall provide epidemiological services to the NCI Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. The Contractor shall 1) provide scientific expertise for the protocol projects; 2) provide guidance relating to the epidemiological and PLCO related studies that are supported by the EDRG; 3) update the Project Officer to new advances in the mechanisms or strategies of early detection and screening, that may be relevant to DCP; 4) provide recommendations on the epidemiological aspects of planning for the future of EDRG as defined in the EDRG mission statement; 5) attend meetings relating to the conduct of the PLCO Trial; 6) serve as Chair of the PLCO Behavior and Nutrition Subcommittee, serve as Chair of the PLCO Analysis, Cost-effectiveness, and Modeling Subcommittee and serve as Chair of the Endpoint Verification Committee (EVC); 7) provide recommendations on epidemological aspects of data analysis and modeling in the PLCO trial as discussed by the above committee which the contractor chairs; 8) develop recommendations for further data analysis and modeling approaches in the PLCO trial; 9) provide interpretation of the results of data analysis and modeling in the PLCO trial and participate as a contributing author or reviewer for any publications that may come from PLCO data that is deemed sufficiently mature; 10) provide recommendations on epidemiological aspects of HRQL and CE studies in the PLCO trial; 11) provide recommendations related to design of studies that will impact on assessment of health-related quality of life (HRQL) and cost effectiveness (CE) studies in the PLCO trial; 12) develop recommendations for further studies of HRQL and CE in the PLCO trial and shall provide his interpretation of results of the studies for HRQL and CE in the PLCO trial; 13) shall provide recommendations for the pathology review in the PLCO trial; 14) attend meetings of the pathology review committee to provide guidance and recommendations on the protocol and procedures for the pathology review; 15) review decisions of the pathology review committee in order to identify and to provide recommendations in resolving difficulties in the application of pathology review criteria; and 16) review all Endpoint Verification folders (ACRIN and LSS) for completeness, the criteria for which will be established by the Government, and shall complete the Cause of Death Questionnaire (CDQ). Dr. Miller is the only known source to the NCI researchers with this knowledge and expertise who can meet their needs. Dr. Miller developed the PLCO Death Data Review Protocol and the Pathology Review Protocol for PLCO and negotiated all aspects of these protocols with the Principal Investigators. He developed the National Lung Screening Trial (NLST) endpoint verification protocol which is currently being used to determine the cause of death of NLST participants. He analyzed the Quality of Life and Cost Effectiveness needs of the PLCO trial and directed the development of pilot projects to establish availability of data and suitability of analysis approaches. Dr. Miller also participates in annual working meetings of IPSTEG as a representative of the PLCO. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI researcher to determine if it can meet the requirements of this synopsis. An original and one copy of the capability statements must be received in the Contracting Office by 1PM EST (local Washington, D.C. time) on September 7, 2005. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA) in order to receive an award. Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS: 541990; Size Standard is 6 million.
- Record
- SN00876801-W 20050825/050823211849 (fbodaily.com)
- Source
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