National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

R -- PROFESSIONAL, ADMINISTRATIVE, AND MANAGEMENT SUPPORT SERVICES. SOL RFQ-NCI-80107 DUE 041098 POC Cynthia Brown, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer The National Cancer Institute (NCI) proposes to procure scientific support services for the ongoing NCI Prostrate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial from Dr. Anthony B. Miller, Senior Epidemiologist, Office of the Director, International Agency for Research on Cancer, 150 cours Albert Thomas, 69372 Lyon cedex 08, France. The PLCO, which involves multiple study centers, is a large-scale, randomized study to determine whether certain screening tests will reduce the number of deaths from the associated cancers. An experienced epidemiologist is required to provide scientific expertise for the following projects that support the PLCO: 1) Health-related quality of life (HRQOL) and cost-effectiveness (CE) studies in the PLCO trial, 2) Death Review in the PLCO trial, 3) Pathology review in the PLCO trial, and 4) Preparation of scientific papers for the PLCO trial and the International Prostrate Screening Trial Evaluation Group (IPSTEG). The activities under these projects require thorough familiarity with the existing protocol design in order for efficient implementation of protocols within the PLCO trial. HRQOL and CE Studies: The Contractor shall review and prepare critiques of five ongoing PLCO pilot studies to investigate issues regarding information sources, quality, and availability with regard to the HRQOL and CE studies. Based on the investigation, the Contractor shall: 1) identify gaps in the knowledge base and provide direction for the design of the projects, 2) direct the design of the overall HRQL and CE assessments trial wide, 3) organize and lead a workshop to review the results of these two studies, 4) edit the minutes and conclusions from the workshop, 5) develop recommendations for further study of HRQL and CE studies, and 6) provide expert guidance on HRQL and CE data collection and quality assurance to the Project Officer. Death Review in the PLCO Trial: The Contractor shall review and critique the final protocol document and submit a written report of findings to the NCI Project Officers. In concert with the Death Review, the Contractor shall: 1) review the credentials of possible members for the Death Data Review Committee (DDRC) and provide guidance to the Project Officers regarding the DDRC constitution, 2) attend the initial meeting of the DDRC to provide guidance on implementation of the protocol for the death review process, 3) review initial DDRC decisions to identify difficulties in applying the death review criteria, and 4) work with DDRC members to resolve issues that could adversely effect the death review protocol. Pathology Review in the PLCO Trial: For the Pathology Review, the Contractor shall: 1) provide expert guidance to NCI in selecting the lead pathologist through participation in credential reviews and interviews, 2) provide expertise to the lead pathologist in selecting members for the Pathology Review Committee (PRC), 3) work with the PRC and PLCO contractors to implement the protocol and any revisions, 4) attend the initial PRC meeting to provide guidance on protocol and procedures for pathology review, 5) review initial decisions of the PRC to identify difficulties in applying review criteria, 6) provide guidance to PRC members on issues that could impede the pathology review protocol, 7) participate in site visits and audits of screening centers in order to review quality practices and charts and to recommend corrective actions via written reports, and 8) participate in analyses of quality assurance data. Preparation of Scientific Papers for the PLCO Trial and IPSTEG: The Contractor shall draft the scientific papers regarding Pathology, Death Data Review, and Quality Assurance, as well as coordinate the contributions of other team members and assure that the manuscripts are promptly completed and dispatched for publication. Other duties include attending the European Randomized Studies on Prostrate Cancer (ERSPC) and the US and European IPSTEG meetings to review data and finalize tables/text. This notice is a combined synopsis/solicitation and NCI does not intend to issue a separate solicitation. This solicitation, RFQ-NCI-80107, is set-aside for small business with a Standard Industrial Classification Code of 8733. Dr. Anthony B. Miller is the only source known to NCI that can meet these requirements. However, if any interested party believes it can meet the above specification, it may submit a statement of capabilities. Information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Capability statements must be received in the contracting office within 15 days after the publication date of this notice. 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. (0084)

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