SOURCES SOUGHT
A -- Research and Development Sources Sought for a Clinical Coordinating Center for the Women's Health Initiative 2010-2015 Extension Study
- Notice Date
- 2/24/2010
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NHLBI-RDSS-11-011
- Archive Date
- 3/26/2010
- Point of Contact
- Jeffrey A Williams, Phone: (301) 435-0331, Peggy D. Mills, Phone: (301) 435-0351
- E-Mail Address
-
williamsja2@nhlbi.nih.gov, millsp@nhlbi.nih.gov
(williamsja2@nhlbi.nih.gov, millsp@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R&D) Sources Sought notice for a Clinical Coordinating Center (CCC) for the Women’s Health Initiative 2010-2015 Extension Study. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Small Businesses are encouraged to respond. 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. III. Project Requirements A.Study Coordination Activities 1.Maintain a high level of cooperation and coordination with WHI Investigators and the NHLBI Project and Contracts Offices. 2.Provide a Manual of Operating Procedures to accomplish the goals of the WHI 2010 – 2015 Extension; distribute to WHI Regional Centers and Project Office. 3.Provide central adjudication and limited outcomes liaison staff to assist the WHI Regional Centers in outcomes ascertainment; monitor Regional Center performance in outcomes ascertainment. 4.Coordinate and support investigator effort for active participation in study management, scientific investigations, and writing groups. 5.Coordinate, participate in, and provide any information necessary for study committee conference calls and meetings, including minutes and other correspondence as needed. B. Training Activities 1.Train WHI Regional Center staff as necessary in data collection, entry, and management, and outcomes ascertainment procedures. C. Data Collection Activities (CCC Duties) 1.Obtain informed consent from current WHI Extension subjects through central mailings. 2.Retain study participants over the 5 year follow-up period (October 2010 – September 2015). 3.Revise current data collection forms as necessary. 4.Develop data collection and management procedures. 5.Conduct follow-up mailings of data collection forms for outcomes ascertainment and selected exposures to participants enrolled in the WHI Extension. 6.If funding becomes available and so directed by the Contracts Office, develop and implement procedures for collecting blood and physical measurements from approximately 8000 participants over age 80 via in person visits. 7.Search the National Death Index annually to locate matches for WHI participants. Obtain death certificates as appropriate. 8.Obtain CMS data on WHI participants at regular intervals; merge with WHI database. D. Data Collection Activities (Regional Center duties for participants at the former Seattle and LaJolla Field Centers) 1.Enroll current WHI participants into the WHI 2010 – 2015 Extension (RCs follow-up with non-responders to central mailings only). 2.Retain study participants over the 5 year follow-up period (October 2010 – September 2015). 3.Document clinical outcomes in hormone trial participants for an additional 5 years. Collect participant self-reported outcomes and selected exposure data (non-responders to annual central mailings only), investigate self-reports by collecting supporting medical records, forward case packets for central adjudication, and record outcomes into the WHI database as directed in the manual of operating procedures. 4.Assess clinical outcomes in African American and Hispanic participants for an additional 5 years. Procedures will parallel those for the hormone trial participants, as in item 3 above. 5.Obtain self-reported clinical outcomes and selected exposure data in the remaining cohort (non-responders to annual central mailings only). Current return of these central mailings is 93% annually. 6.If funding becomes available and so directed by the Contracts Office, document cancer and other clinical outcomes in remaining former DM trial and OS participants for an additional 5 years. Procedures will parallel those for the hormone trial participants, as in item 3 above. E. Data Management Activities 1.Maintain WHI database including quality assurance and quality control procedures. Maintain confidentiality and security of data. Provide expertise necessary to integrate data from outside the WHI (e.g. CMS) into the WHI database. 2.Maintain and update as needed the WHI web-based data entry and management system, including quality control procedures. All web applications must comply with section 508, see http://www.section508.gov/. 3.Develop/update an information systems security plan in accordance with Table 3 of the Federal Information Security Safeguard Requirements Summary at http://irm.cit.nih.gov/security/table3.htm. 4.Coordinate the purchase and support the installation of any hardware and software needed to acquire and transmit data according to manual of operating procedures. 5.Collect, edit, store, analyze and report on data from the WHI Regional Centers in accordance with the protocol and manual of operating procedures. 6.Prepare NHLBI Data Repository datasets in accordance with the NHLBI Limited Access Data Clause and the NHLBI Policy for Distribution of Data. F. Biomedical Activities 1.Maintain the WHI biologic specimen resource in accordance with the protocol and manual of operating procedures. If funding becomes available and so directed by the Contracts Office, oversee the addition of approximately 8000 blood specimens to the repository. 2.Track inventory of available specimens. 3.Provide specimens to investigators in accordance with study policies/procedures for access to specimens. 4.Oversee analyses of biologic specimens to test specific hypotheses as required by the protocol and manual of operating procedures. 5.Conduct feasibility and quality assurance studies as needed, maintain pooled reference samples. G. Reporting Activities 1.Analyze the relative frequencies of outcomes of interest across treatment groups and report the data annually for the Observational Studies Monitoring Board (OSMB), or as requested by the Project Officer. 2.Prepare and distribute interim Regional Center enrollment reports. 3.Prepare and distribute interim Regional Center performance reports. 4.Prepare and distribute annual study progress reports. H. Scientific Activities Note: In 2011, NHLBI intends to release a Broad Agency Announcement to solicit proposals for use of the WHI data and biologic resources to build on knowledge gained under the current program. The CCC’s role in support for the BAA contractors will be further defined in the BAA. The following items are included in the current Statement of Work: 1.Provide scientific & operational expertise to support WHI investigators and non-WHI scientists in preparing to use the WHI resources, including the WHI database and biologic specimens, including maintenance of WHIScience.org. All web applications must comply with section 508, see http://www.section508.gov/. 2.In collaboration with WHI and other ancillary study investigators, generate hypotheses and design approaches to testing hypotheses that complement WHI study results. Generate paper proposals; participate in manuscript development. 3.Participate in evaluation of proposals for manuscripts and ancillary studies. 4.As required, provide effort and resources for contractually-funded ancillary studies. 5.Conduct pilot laboratory studies, as needed. The Contractor shall initiate this work only after approval from the appropriate study committees and when so directed by a written Work Assignment from an NHLBI contracting officer. 6.Submit plan for coordination of and participate in scientific activities across various disciplines, including but not limited to cardiovascular, cancer, aging, health services research, and genetics. Propose methods of engaging scientific expertise not available among WHI investigators. Note: most scientific activities are expected to be WHI-wide collaborations. 7.Propose estimated numbers of WHI-approved publications and ancillary studies each year. 8.Propose methods to engage investigators from the former FCs in Seattle and LaJolla. IV. Anticipated Period of Performance A cost reimbursement contract is anticipated with an award date on or about April 2011 and a period of performance of five years. V. Capability Statement NHLBI is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this research effort. At a minimum, prospective Offerors must provide their documented capabilities in the following areas: 1.Demonstrate past experience in and current capability to develop collegial relationships to allow peak performance in collaborative biomedical clinical projects, especially the ability to work within long-established groups. Specifically, prospective Offerors must provide a description of previous large multi-center clinical research projects in which the organization and proposed personnel have participated. 2.Demonstrate past successes in re-consenting participants under a multi-center clinical research project; maintaining maximum participant retention. Demonstrate ability to obtain re-consent within a collaborative, regional model with central IRB support. 3.Training and experience in and knowledge of cardiovascular, cancer, aging, functional status assessment, genetics, and health services research. Demonstrate ability to train and mentor junior and mid-level investigators. 4.Document training and experience in data processing and biostatistical analysis of large and complex datasets, and the use of survival analysis and competing outcomes statistical approaches to clinical outcomes data. Document the capability to develop sufficient computer systems for storage, retrieval, and analysis of clinical research data and personnel including computer programmers and data managers to develop strategies for the transfer of existing data into the new system, and to support the current and expanded database. 5.Document training and experience in regulatory medicine as it applies to data collection and informed consent and HIPAA requirements. 6.Document training and experience with quality assurance and quality control, conducting site visits to assess site performance, and adherence to program procedures, timelines and program management and oversight. 7.Document that facilities are available for receiving, processing, storing, and retrieving medical data accurately and efficiently and blood specimen handling and storage. We ask that you address items 1 through 7 in your response. The capability statement shall not exceed 20 single sided or 10 double sided pages in length. Please include your DUNS number and identify your size classification relative to North American Industry Classification System (NAICS) code of 541712 for this requirement. Include a statement whether or not you are a small business; HUBZone small business; service-disabled, veteran-owned small businesses; 8(a) small business; women-owned small business; or small disadvantaged business in order to assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. One original and two (2) copies of the capability statement must be received at the following address no later than Thursday, March 11, 2010: Contracting Office Address: Jeffrey A. Williams, Contract Specialist, National Heart, Lung, and Blood Institute, NIH, DHHS Office of Acquisitions, DERA 6701 Rockledge Drive RKL2/6100 MSC 7902 Bethesda, Maryland 20892-7902 (For overnight deliveries use zip code 20817; no MSC is required) Do not include budget information. When submitting this information, please refer to Research and Development (R&D) Sources Sought Notice HHS-NIH-NHLBI-RDSS-11-011. Responses that do not adhere to these guidelines will not be considered. This notice will close fifteen days from its posting. 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).”
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