The Women's Health Initiative - Regional Centers
Added: Aug 06, 2014 8:58 am
The National Heart, Lung, and Blood Institute (NHLBI), NIH 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-2016-01-CM) on or about August 21, 2014 for the WHI Regional Centers .Since 1993, some 41 contractors and a coordinating center contractor have been involved in the recruitment, treatment strategies, follow-up, collection, and analysis of data, and reporting of results on 161,808 participants from clinical centers across the United States. The Study objectives are detailed below.Background and Purpose of the WHI: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 third (2015-2018) 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 (2015-2020) 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 trialsThis renewal (2015-2020) will fully realize the potential of the restructuring and innovations introduced during the current renewal period. The structure of a Coordinating Center, four Regional Centers, and committee/scientific interest groups will be maintained.Regional Center Functions:• Participant follow-up and events adjudication: • Continue mentoring young investigators though the Regional Centers. • Continue recruiting non-WHI investigators to collaborate or to analyze the data themselves. In the majority of cases WHI data are now being analyzed by the investigators themselves.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 http:fedbisopps.gov. Potential Offerors are responsible for downloading the RFP and any/all attachments. It is also Offerors' responsibility to monitor the FEDBIZOPPS for any amendments to the RFP. It has been determined that this acquisition will be set aside for small business concerns under the North American Industry Classification System (NAICS) code 541712.
NHLBI-CSB-WH-2016-01-CM Department of Health and Human Services National Institutes of Health
8/6/14, 8:58 AM The Womens Health Initiative Regional Centers
Added: Jun 18, 2014 3:46 pm
The National Heart, Lung, and Blood Institute (NHLBI), NIH is seeking qualified sources to perform a follow up to the Women's Health Initiative Study. NHLBI anticipates the issuance of a request for proposals (NHLBI-CSB-WH-2016-01-CM) on or about August 13, 2014. Since 1993, some 41 contractors and a coordinating center contractor have been involved in the recruitment, treatment strategies, follow-up, collection, and analysis of data, and reporting of results on 161,808 participants from clinical centers across the United States. The Study objectives are detailed below.Background and Purpose of the WHI: 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 third (2015-2018) 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 (2015-2018) 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 trialsThis renewal (2015-2018) will fully realize the potential of the restructuring and innovations introduced during the current renewal period. The structure of a Coordinating Center, four Regional Centers, and committee/scientific interest groups will be maintained. Regional Center Functions:• Participant follow-up and events adjudication: • Continue mentoring young investigators though the Regional Centers. • Continue recruiting non-WHI investigators to collaborate or to analyze the data themselves. In the majority of cases WHI data are now being analyzed by the investigators themselves.This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer at the above noted address. The capabilities statement shall include 1) the total number of employees, 2) the professional qualifications of the scientists, medical experts, and technical personnel as it relates to the project management aspects as in the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous research projects in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program (i.e. organizational experience specifically related to this requirement) The information provided must also establish the organization's status as a small business. Copies of the capabilities statement must be sent electronically to the point of contact provided above prior to response date listed. If this program is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. The RFP will be available in FedBizOpps.
NHLBI-CSB-WH-2016-01-CM Department of Health and Human Services National Institutes of Health
6/18/14, 3:46 PM