SOLICITATION NOTICE
B -- Testosterone Supplementation in Relation to Prostate Cancer and Cardiovascular Disease: An Analysis Nested within the HealthCore Integrated Research Database (HIRD℠)
- Notice Date
- 7/21/2014
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02CP42586-57
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
reyes.rodriguez@nih.gov
(reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source basis services access to study populations drawn from the HealthCore Integrated Research Database (HIRD℠) to enable analyses of testosterone supplementation user groups compared with PDE5I user groups, and non-user groups to assess risks of cardiovascular disease and prostate cancer from HealthCore, Inc., 800 Delaware 52, Wilmington, DE 19801. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501- (a)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. NCI/DCEG/EBP believes There is extensive evidence of the essential role of sex steroid hormones in the growth, development, and maintenance of healthy prostate epithelium. In a recent prospective study, Epidemiology and Biostatistics Program (EBP) has demonstrated that high testosterone levels (high androgenicity) are associated with an increased risk of aggressive prostate cancer in younger men. Combined with the fact that androgen deprivation therapy (ADT) is a first-line therapy for prostate cancer underscores the hypothesis that testosterone supplementation may actually fuel indolent prostate cancer. In addition, recent evidence suggests the possibility that testosterone supplementation is associated with excess risk of adverse cardiovascular events (Basaria et al., NEJM, 2010, (Xu, et al. 2013) and with myocardial infarction and stroke (Vigen et al., JAMA 2013) and myocardial infarction, (Finkle et al. PLOS ONE 2014). Testosterone supplementation has been increasing extraordinarily rapidly, including among younger men and among those without hormone measurement, suggesting that the indications for prescription have markedly expanded. Therefore, EBP proposes to assess associations between testosterone supplementation and prostate cancer and cardiovascular disease risks in these large medical databases. Contractor Requirements The Contractor shall: 1. Obtain IRB approval to cover all HealthCore activities throughout the contract lifespan. 2. Execute Data Sharing Agreements (DSA) with investigators at NCI. 3. Provide secure access via Citrix Server to de-identified study populations drawn from fully-insured members' data contained within the HIRD℠. The HIRD℠ includes enrollment files, pharmacy claims, medical claims (with diagnostic and procedure codes), and-for a subset of members-outpatient laboratory results data. Citrix Server enabled study populations shall be drawn from approximately 18.5 million fully-insured members with at least one day of enrollment between 01/01/2006 and 06/30/2013. This includes 104,000 individuals who have at least one testosterone supplementation prescription, 87,000 of whom have at least 6 months of continuous enrollment following the first testosterone supplementation prescription. All dates shall be provided in MM/YYYY format to enable comparison populations to be selected and matched on factors such as age at prescription, length of observed time in database prior to prescription, and length of observed time to outcome or end of follow-up post prescription. 4. Provide indirect access to study populations drawn from researchable members' data contained within the HIRD℠ to enable NCI analyses to be run on this larger, non-Citrix enabled dataset. Researchable members comprise fully-insured members as well as those ASO groups that have agreed to make their data available for research. The HIRD℠ includes enrollment files, pharmacy claims, medical claims (with diagnostic and procedure codes), and-for a subset of members-outpatient laboratory results. Non-Citrix Server enabled study populations shall be drawn from approximately 29 million researchable lives with at least one day of enrollment between 01/01/2006 and 06/30/2013. This includes 166,000 individuals who have at least one testosterone supplementation prescription, 139,000 of whom have at least 6 months of continuous enrollment following the first testosterone supplementation prescription. All dates shall be in MM/YYYY format to enable comparison populations to be selected and matched on factors such as age at prescription, length of observed time in database prior to prescription, and length of observed time to outcome or end of follow-up post prescription. 5. Medical claims contained within the HIRD℠ include ICD-9 diagnosis codes and associated dates of service. Cancer type of site-specific cancers including prostate cancer, as well as cardiovascular events shall be determined based on diagnosis codes from the medical claims. 6. Medical claims contained within the HIRD℠ include CPT codes and associated dates of service. PSA tests and dates for all PSA tests on members of study populations, as well as testosterone tests and dates for all testosterone quantitation tests that were administered shall be determined based on CPT codes from the medical claims. PSA test values and testosterone quantitation values is estimated to be available for approximately 30% of those tested using outpatient laboratory data. 7. The study database shall also include date of birth, date(s) of enrollment, dates of procedures with accompanying ICD/CPT/HCPCS codes, dates of prescriptions with accompanying drug codes, dates of outcomes (cardiovascular and cancer) with accompanying ICD-9 codes for members of study populations. All dates shall be in the MM/YYYY format. All codes shall be at the most granular level native to the database as to enable correct left truncation, right-censoring, and sub-selection of populations for sensitivity analyses (e.g., assessing/stratifying/excluding benign prostatic hyperplasia). 8. Provide assistance and expertise on HIRD℠ data access, population selection and to inform NCI's analyses. 9. Provide assistance with indirect access to the larger HIRD℠ database of researchable members' data to enable NCI analyses to be conducted. 10. Provide the study cohort data in a de-identified format as set forth by an actuary review or limited data set to NCI in an accessible format (such as.dta,.csv) no later than 12 months from the date of the award. 11. Be part of monthly conference calls (more regular if needed) to ensure adequate progress, assistance and expertise from HIRD℠ to assist NCI researchers with the data access and population selection issues. 12. All data generated shall be the property of the U.S. Government. Government Responsibilities NCI program staff will review draft deliverables for review and approval. NCI will also provide the funding required for the contractor to perform the tasks outlined in this document. Reporting Requirements and Deliverables 1. One month after initiating database curation the Contractor shall provide the government with an interim report by email. This report shall provide descriptive information of the curated dataset for analysis by NCI researchers. 2. The second deliverable is provision of secure access via Citrix Server to study dataset which shall include enrollment files, pharmacy claims, and medical claims (with diagnostic and procedure codes) for all individuals specified above in this Statement of Work. 3. The third deliverable shall be provision of all results from the NCI analytic code being ran on the study population as required for the COR to draft versions of the two primary manuscripts suitable for publication in scientific journals. 4. The fourth and final deliverable shall be provision of any final datasets required between submission and full acceptance by scientific journals of the two primary scientific manuscripts. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other 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. Responses must be received in the contracting office by 11 AM EST, on August 04, 2014. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@nih.gov. A determination by the Government not to compete this proposed requirement 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02CP42586-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02CP42586-57/listing.html)
- Place of Performance
- Address: Contractor's Site, United States
- Record
- SN03432142-W 20140723/140721235104-aa1902628bc3902cb3c786fc5b805b24 (fbodaily.com)
- Source
-
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