Presolicitation Notice for a Clinical Coordinating Center for the Women's Health Initiative 2010-2015 Extension Study

The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive, sole source basis with the Fred Hutchinson Cancer Research Center (FHCRC), the Clinical Coordinating Center (CCC) for the Women's Health Initiative (WHI) to award a Follow-up Study from 2010-2015. The cited authorities are 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. This effort will be a five year follow-up of the WHI participants. This contractor has been involved in the recruitment, treatment strategies, follow-up, collection and analysis of data, and reporting of results on 161,808 participants from 40 clinical centers across the United States under the current contract number N01-WH-2-2110. The incumbent contractor has the unique capacity to provide these required services to NHLBI for the follow-up of the study. Inherent duplication of costs to the Government and unacceptable delays in completing the project make competition unfeasible for this study. The objectives of the study are detailed below. I. Background and Purpose of the WHI The Women's Health Initiative (WHI) was established to elucidate the etiology and prevention of major causes of disability and death in older women (age range 50-79), namely cardiovascular disease, cancers of the breast, colon and rectum, and hip fractures. The program included three clinical trials in a partial factorial design (N=68,132) and a large observational study (N=93,677) for a total of 161,808 participants enrolled (17% minority). The program collected data on outcomes and exposures that span across most disease domains. During the first phase of the program (1993-2005) the three clinical trials and the concurrent observational study were completed. The trials of hormone therapy were stopped early, in 2002 for estrogen plus progestin because of harm for Coronary Heart Disease (CHD), stroke, Venous Thrombo embolism (VTE) and breast cancer, and in 2004 for estrogen alone because of harm for stroke and VTE and lack of benefit for CHD. In an ancillary study, women over age 65 had an increased risk of dementia in both hormone arms. The trials of low fat dietary modification and of calcium and vitamin D continued to 2005 as planned. The currently ongoing renewal of WHI (2005-2010) enrolled 115,405 women (77% of those eligible) at 40 field centers. The post-stopping of therapy experience of the clinical trial participants in regard to trial exposures and clinical events are being monitored. The 3-year data after stopping estrogen plus progestin have been published, and the other trials will publish post-stopping data in 2010. The additional outcomes accrued in the observational study have been used to extend the clinical trial findings and are being utilized in several ancillary and consortium studies. The WHI data and biologic resources have been made widely available to the scientific community, and in particular two rounds of Broad Agency Announcements have funded 22 investigations utilizing the biologic samples. The current annual retention rate of the cohort is 98%. II. WHI 2010-2015 Extension Study Objectives A further 5-year observational WHI follow-up study is anticipated from October 1, 2010 through September 30, 2015. During this time, all WHI participants will be invited to provide informed consent for continued follow-up of clinical outcomes, return of study questionnaires, and willingness to be approached for future ancillary studies including clinical trials. It is estimated that a total of ~100,000 women (85% of living participants, projected age range 62-95 with 35% over age 80) will enroll in the 2010-2015 extension. While it is well known that cardiovascular disease (CVD) is the major cause of death in American women, it is less appreciated that the vast majority of these deaths occur in older women (women over the age of 80). They account for an increasing proportion of the CVD morbidity and mortality, and suffer from a number of important phenotypes, which include diastolic heart failure, hypertension, stroke, peripheral arterial disease, and atrial fibrillation. Elderly women comprise the most rapidly growing demographic in the US population, yet only ~4,500 women over the age of 80 are currently being following in other NHLBI cohort studies. The WHI has a very large cohort of older women with a demonstrated enthusiasm for clinical research; the cohort is rich in clinical, phenotypic, and genotypic data; and it is supported by a strong research infrastructure. This follow-up takes advantage of the WHI cohort and its investigators to launch the next generation of critically important cardiovascular research projects that target older women. The renewal plans to continue support for following the cohort from 2010-2015, with several modifications to enhance its scientific value. The depth of the follow-up will be increased for two important sub-cohorts (hormone trial participants, and African American and Hispanic participants with Genome- Wide Association Study (GWAS) data, N~24,000, with ~8,400 over age 80) but will be scaled back to collect self-reported data only for the remaining (~76,000) participants from the other study trials and the observational study. In addition to the continued follow-up of the hormone trial participants to evaluate long term effects of treatment, both the hormone trial and minority populations will serve as observational studies with a new focus on three CVD outcomes with substantial burden in older women (heart failure, atrial fibrillation, and venous thromboembolism) while continuing current adjudication of CHD, stroke, cancer, and other outcomes. The combined hormone trial and minority GWAS cohorts will have substantial minority representation (~28% African American, 12% Hispanic, and 58% White). The CCC's expected responsibilities that will continue during the follow up phase include (but are not limited to) preservation of the WHI cohort and obtaining informed consent for ongoing participation; data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and sub-studies; lead the development of the protocol and manuals of procedures development; continue to support a morbidity/mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the field centers; maintain the biological specimen laboratory; solicit and monitor laboratories; coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government. The restructuring of the WHI field centers into up to 5 regional field centers will include funding for coordinating regional activities including, documentation of clinical outcomes, engaging investigators inside and outside current centers to propose analyses and ancillary studies, to perform distributed data analyses, and to train new investigators. Having a limited number of regional field centers will streamline study management and will facilitate ancillary studies within the region, and across regions, compared to having 40 field centers. This notice will close fifteen days from its posting. This is not a request for proposals (RFP). The estimated award date is April 1, 2011. All responsible sources may submit capability statements demonstrating their ability to perform this research effort on the same study participants and are encouraged to contact the Contract Specialist at least five business days prior to the close of this notice. Questions may be directed to the Contract Specialist, Jeffrey Williams, williamsja2@nhlbi.nih.gov, 301-435-0331. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).