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

A -- DIETARY INTERVENTION STUDY IN CHILDREN (DISC) HORMONE ANCILLARY STUDY DATA MANAGEMENT AND STATISTICAL SUPPORT SOL RFQ80162-NS DUE 071098 POC Patricia Haun, (301) 496-8613 The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics proposes to procure the services of Maryland Medical Research Institute, 600 Wyndhurst Ave., Baltimore, MD 21210. The services are needed for the completion of a Dietary Intervention Study in Children (DISC) Hormone Ancillary Study Data Management and Statistical Support. Background: The DISC Hormone Study was conducted by NCI ancillary to a National Heart, Lung, and Blood Institute (NHLBI) sponsored multi-center clinical trial funded through a cooperative agreement. NCI was awarded concept approval to co-fund DISC grants/cooperative agreements with the clinical centers and the coordinating center for collection and analysis of data through Fiscal Year 2000. However, NHLBI discontinued funding of the main DISC trial in 1998. Final DISC clinic visits were completed prior to this time, and hormone assays on serum from these visits are scheduled for completion in May 1998. Support of the DISC coordinating center at the Maryland Medical Research Institute is needed for data management and statistical analyses of hormone assay results. Specifically, the DISC Hormone Ancillary Study is the only clinical trial involving children to evaluate the influence of diet on hormones that are believed to play a role in breast and prostrate cancers. Requirement: The Contractor shall work with the NCI Project Officer, NCI and NHLBI statisticians, DISC investigators, and others to accomplish the work under this procurement. Specific tasks include: 1) perform edit checks on hormone data received from the laboratory; 2) integrate hormone data into the file management system for DISC data files; 3) create Statistical Analysis Systems (SAS) S+, and other analysis files as needed; 4) perform statistical analyses of quality control samples to assess hormone laboratory performance; 5) perform univariate and multivariate statistical analyses to meet the objectives described above as requested by the NCI Project Officer or convener of a DISC Hormone Ancillary Study writing group; likewise, when requested by the Project Officer or writing group, prepare analysis files and provide consultation on statistical analysis; 6) assist in preparation of presentations and manuscripts; 7) prepare a final DISC Hormone Ancillary Study data file including hormone data, intervention assignment, and participant characteristics as determined by the NCI Project Officer at completion of the study. Additionally, the Contractor shall provide a separate file including all hormone results on quality control samples. Since this study has been ongoing at Maryland Medical Research Institute, the study must continue under the same conditions in order to maintain reliability; furthermore, the data in Maryland Medical Research Institute's DISC Hormone Ancillary Study is proprietary in nature. This notice is a combined synopsis/solicitation and NCI does not intend to issue a separate solicitation. This solicitation, RFQ80162-NS, is not set-aside for small business; however, the Standard Industrial Classification Code is 8733. Since the referenced DISC data is proprietary to Maryland Medical Research Institute and transfer of such a study could affect the integrity of the final data and analysis, Maryland Medical Research Institute 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. Posted 06/26/98 (0177)

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