SOLICITATION NOTICE
A -- Women's Health Initiative - Clinical Coordinating Center
- Notice Date
- 1/6/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-WH-2016-02-CM
- Archive Date
- 2/4/2015
- Point of Contact
- Iris Merscher, Phone: 301-435-0365, Cornelius Moore, Phone: (301) 435-0343
- E-Mail Address
-
iris.merscher@nih.gov, mooreco@mail.nih.gov
(iris.merscher@nih.gov, mooreco@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), is seeking qualified sources to perform a follow up to the Women's Health Initiative (WHI) Study. NHLBI anticipates the issuance of a request for proposals (NHLBI-CSB-WH-2016-02-CM) on or about January 21, 2015 titled WHI Clinical Coordinating Center. Background: The NHLBI, Extramural Research Program, Division of Cardiovascular Sciences (DCVS), Women's Health Initiative Branch (WHI) supports clinical trials and observational studies to improve understanding of the causes and prevention of major diseases affecting the health of women. Current studies focus on cardiovascular disease, cancer, and fractures, in collaboration with other NIH Institutes: NCI, NIAMS, NIA, NINDS, and ORWH. The large multi-center observational epidemiology studies seek to identify risk markers for disease or better quantify known markers using questionnaire, clinical examination, and laboratory data. The large and long-term multi-center clinical trials test promising but unproven interventions such as hormone therapy, diet, and supplements to prevent major diseases and evaluate overall effects on health. The Branch has established an infrastructure to support the utilization of data and blood samples from the studies by the scientific community. I. BACKGROUND INFORMATION - WOMEN'S HEALTH INITIATIVE 1992-2005: In 1991 Dr. Bernedine Healy obtained funding for the WHI to study the etiology and prevention of the major chronic diseases of postmenopausal women. The study enrolled 68,132 women age 50-79 years in an overlapping set of randomized controlled clinical trials and another 93,676 women in an observational study (total = 161,808). • The randomized trials examined the health benefits and risks of postmenopausal hormone therapy, low fat dietary pattern, and calcium and vitamin D supplementation. Together, these trials have made important contributions to understanding the value of commonly used prevention strategies. Findings from the trial of hormone therapy led to a turnaround in medical practice and decreases in rates of breast cancer and ovarian cancer. The net societal value of the trial of estrogen plus progestin over the 10 years since its publication is estimated to be ~ $140 for every $1 invested by NIH/NHLBI. • The data from the observational study has been used for a large variety of epidemiologic studies and have proven invaluable to explain discrepancies between trial findings and observational studies. 2005-2010: The first renewal continued follow up of outcomes in trial participants and increased study power for subgroups of observational study participants (N=115,407). 2010-2015: The current second renewal period (N=93,558) has aims similar to those for the proposed third renewal period. Significant changes were introduced to enhance cost efficiency and to increase the value of the cohort for prevention research. Cost savings realized were applied to additional research and to mentoring young investigators. • The original 40 clinical centers were streamlined to 4 regional centers. The outcomes process was largely centralized to the CCC. Regional centers contact non-responders, collect medical records, and participate in study management, scientific leadership, and mentoring. • Outcomes adjudication was scaled back to 22,283 participants in the Medical Records Cohort (MRC). The MRC comprises all consenting African American and Hispanic women and/or women previously enrolled in the hormone trials. The remaining 71,245 women in the Self-Report Cohort (SRC) are followed at much reduced cost through self-report, CMS, and NDI data queries. • The Long Life Study (LLS) is a subset of the MRC and comprises 7875 women age 63-97 years who were examined at home. • WHI has demonstrated utility of CMS data with positive predictive values of 86-95% for a range of cardiovascular outcomes when compared with adjudicated outcomes. • Two grant proposals for large, simple, low-risk prevention trials have been submitted for funding; one has been funded by private industry. • By virtue of its large size, the WHI program contributes disproportionately to consortium efforts and to public datasets. • NHLBI funded 3 BAAs to enhance the scientific value of the resource by exploring the relationships of genetic variations, methylation, gene expression and regulation, telomere biology, and metabolomics to coronary risk factors and to clinical coronary disease. Overlap between subjects will allow for an initial exploration of systems biology in relation to coronary disease. The third renewal (2016-2021) supports the Women's Health Initiative (WHI) core operations and the follow up of clinical events. The objectives are to: • Expand knowledge about the determinants of cardiovascular disease in older women (and conversely determinants of successful aging with absence of cardiovascular disease); • Expand the study as a scientific resource for the research community; • Mentor young investigators; • Facilitate a new generation of large simple prevention trials. The current structure consisting of a Clinical Coordinating Center, four Regional Centers, and committee/scientific interest groups shall be maintained. Coordinating Center Core Functions: These functions relate to maintaining and updating the data and biologic specimens as well, as the continuing follow-up of outcomes in ~85,000 participants. The Core functions of the Coordinating Centers are: • Coordinate data collection for this large and complex study; maintain investigator, public, and study participant websites and documentation/data resources; • Make data and biologic specimens available to the research community; • Provide data and analytic support for paper proposals approved by the Publications and Presentations Committee; • Provide data and basic support for proposed ancillary studies and consortium studies; • Deposit curated data into BioLINCC and dbGAP at the required intervals; • Update study files with clinical outcome, laboratory, and ancillary study data; • Provide support for administrative functions such as committee meetings and conference calls; • Provide annual study updates to Steering Committee, NHLBI, and Observational Studies Monitoring Board (OSMB). This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. The requirement will cover 60 months and a "Cost-Reimbursement-Completion" type contract is being considered. The ultimate contract type and funding mechanism will be determined by the NHLBI, based on what fits the project's goals and the available funding. The RFP will be available on the FEDBIZOPPS website at www.fbo.gov. Prospective Offerors are responsible for downloading the RFP and any/all attachments. The Offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The RFP will be available from the FedBizOpps on or about January 21, 2015.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-WH-2016-02-CM/listing.html)
- Record
- SN03609664-W 20150108/150106234726-a6c88b41e452965caa2169c5a251582d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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