SOURCES SOUGHT
A -- The Women's Health Initiative Memory (WHIMS) Suite of Studies
- Notice Date
- 9/9/2015
- 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 Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(AG)-RDSS-15-006
- Point of Contact
- Tawanda Haynes-Brown, Phone: 3014436162, Yvette Brown, Phone: 301-443-8402
- E-Mail Address
-
haynest@mail.nih.gov, yvette.brown@nih.gov
(haynest@mail.nih.gov, yvette.brown@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- HHS-NIH-NIDA(AG)-RDSS-15-006 SOURCES SOUGHT NOTICE This is a Research and Development (R&D) Sources Sought notice. 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. BACKGROUND The Women's Health Initiative (WHI) randomized clinical trials of hormone therapy (HT) were designed to determine whether HT had beneficial effects on health outcomes, especially cardiovascular health, in postmenopausal women. Women without uteri were randomly assigned to take one daily tablet containing either conjugated equine estrogens (CEE), 0.625 mg (Premarin, Wyeth Pharmaceuticals), or a matching placebo, and women with uteri were randomly assigned to take one daily tablet containing either CEE, 0.625 mg, and medroxyprogesterone acetate (MPA), 2.5 mg, (Prempro, Wyeth Pharmaceuticals) or a matching placebo. The WHI Memory Study (WHIMS) was an ancillary study to the WHI and enrolled 7,427 women aged 65 years and older. WHIMS investigated the effects of HT on risk of probable dementia and any cognitive impairment and on changes in global cognition over time. Because WHIMS did not include detailed cognitive assessments of women without cognitive impairment, the WHI Study of Cognitive Aging (WHISCA) was designed as an ancillary study to WHIMS to assess memory and other domain-specific cognitive functions in women free of dementia. WHISCA enrolled 2,305 WHIMS participants at 14 clinical sites on average 3 years after WHI randomization and was conducted under contract number N01-AG-9-2115. The WHI and ancillary WHIMS and WHISCA studies were stopped earlier than planned for both the combination therapy (in 2002) and CEE-Alone (in 2004) because these treatments increased health risks and did not protect against coronary heart disease. Although study medications were discontinued, follow-up assessments have continued. Contrary to expectations, the WHIMS studies showed that CEE+ MPA versus placebo was associated with a significant increase in risk for probable dementia and mild cognitive impairment (Shumaker, Legault et al. 2003), poorer performance on a measure of global cognition (Rapp, Espeland et al. 2003), and greater verbal memory decline over time (Resnick, Maki et al. 2006). CEE-Alone treatment versus placebo in women with prior hysterectomy was associated with a trend toward increased dementia risk (Shumaker, Legault et al. 2004), significantly poorer performance on a measure of global cognition (Espeland, Rapp et al. 2004), but no significant effects on domain-specific cognitive change over time (Resnick, Espeland et al. 2009). WHIMS-MRI was conducted post-trial in approximately 1,400 WHIMS participants to determine whether potential effects of HT on cerebral ischemic disease could explain the adverse effects of HT on cognitive outcomes. Contrary to expectation, HT was not significantly associated with ischemic lesion burden on MRI (Coker, Hogan et al. 2009), but women who had been randomized to active treatment had smaller total brain, frontal and hippocampal volumes compared with women who had been randomized to placebo (Resnick, Espeland et al. 2009). In 2008, WHI clinic visits ceased and WHIMS transitioned to an annual telephone-administered cognitive assessment battery (Rapp, Legault et al. 2012) for the WHIMS Epidemiology of Cognitive Health Outcomes (ECHO) study, which remains active and incorporates some components of the WHISCA assessment. In addition to the WHIMS-ECHO continuation, the WHIMS-Y study to test the "window of opportunity" hypothesis was initiated in 2008, using the telephone assessment protocol to evaluate cognition in WHI participants who had been randomized to HT or placebo at age 50-55 but had not previously received cognitive testing. The WHIMS-Y study tested the clinically relevant hypothesis that HT shortly after menopause would confer benefit to cognitive health later in life. The recently published initial results from WHIMS-Y showed neither harm nor benefit of early postmenopausal HT treatment on cognition more than 10 years later (Espeland, Shumaker et al. 2013). The WHIMS-ECHO and WHIMS-Y studies continue through 2016 (under contract HHSN271201100004C). By the end of the current contract, data collection for WHIMS-Y will be sufficient to address the original scientific questions. It is expected that approximately 2,000 older women in WHIMS-ECHO will remain active in 2016 and that these women will have an average age of 88.2 years. OBJECTIVE The purpose of this contract is to continue prospective follow-ups, including adjudicated diagnostic assessments and cognitive evaluations, of women in the WHIMS-ECHO studies, to provide the scientific community with biostatistical support and infrastructure for analysis of existing and new cognitive and MRI outcomes collected through the WHIMS Suite of Studies, and to provide support for retrieval of WHI biospecimens for investigations of factors related to cognitive and brain aging. The proposed extension of support for the WHIMS Suite of Studies will provide a unique opportunity to gain further insights into the antecedents of cognitive impairment and resilience in a large sample of the "oldest-old" women who have been followed for 20 years. In addition, the vast array of data and biospecimens available through the ongoing WHI studies will provide an opportunity to elucidate the mechanisms underlying age-related cognitive decline, impairment, and resilience. SCOPE AND REQUIREMENTS 1. Continued surveillance of the WHIMS-ECHO cohort. Continue to provide telephone cognitive assessments and central adjudication of diagnoses of cognitive impairment for the WHIMS-ECHO cohort. By 2016, approximately 2,000 women will remain active and as many as 200 additional cases of probable dementia are anticipated over the 2016-2021 period. The mean age of the WHIMS-ECHO cohort in 2016 is projected to be 88.2 years. In addition to continued evaluation of long-term effects of HT on cognitive outcomes and dementia risk, continued dementia screening and cognitive evaluation in the WHIMS-ECHO cohort will provide invaluable information on cognitive aging in relation to other health outcomes, including factors that predict cognitive impairment and those that promote cognitive resilience. Continued assessments of the WHIMS-ECHO cohort will: a. Enhance statistical power to identify predictors of cognitive decline and cognitive resilience. b. Continue investigation of the adverse effects of postmenopausal hormone therapy on cognition as these women pass through the risk period for accelerated cognitive decline and impairment. c. Continue to serve as a national resource on which to build ancillary studies in collaboration with the greater scientific community. 2. Biostatistical support for data analysis, manuscript preparation, and development of ancillary studies using cognitive and MRI outcome data. a. Continue biostatistical support for manuscripts and ancillary studies investigating WHIMS cognitive and MRI data in relation to other WHI and WHIMS outcomes. b. Provide support for extraction of specific genetic information from the WHI GWAS database files and for statistical genetic analysis of projects involving WHIMS cognitive and MRI outcomes. c. Maintain the WHIMS website and provide data coordination with the WHI Clinical Coordinating Center (CCC). 3. Coordinate and support retrieval of stored samples from the central WHI repository. a. Provide support and coordination with the WHI CCC for retrieval of stored biospecimens for projects related to WHIMS cognitive and MRI outcomes. b. Provide a plan for prioritizing funding of sample retrieval, as the number of potential requests is unknown. WORK TO BE PERFORMED Independently, and not as an agent of the Government, the Contractor shall provide all the necessary personnel, facilities, supplies, and services (except for those to be furnished by the Government as specified elsewhere in this contract) to perform the work required by this contract as set forth in this section. A. General Requirements The Contractor shall coordinate the WHIMS-ECHO data collection, including recruitment and scheduling of study participants, administration and scoring of the telephone assessment battery, determination and adjudication of diagnoses of probable dementia and mild cognitive impairment, and data entry and transfer. In addition, the Contractor shall maintain close contact with the main WHI study and assessment schedule to ensure that relevant demographic and clinical variables are available or continue to be collected for WHIMS-ECHO. The Contractor shall: 1) Maintain a high level of cooperation and coordination with WHI Investigators, the WHI CCC, and the Contracting Officer's Representative (COR); 2) Provide supplies, where needed for test administration; 3) Train and supervise staff in the administration and scoring of the tests and other evaluation instruments; 4) Perform central adjudication of diagnoses of dementia and mild cognitive impairment; 5) Perform computer data entry and transfer of data to the COR; 6) Maintain the WHIMS web site; 7) Provide biostatistical and other support for data analysis, manuscript development, and preparation; 8) Provide support for extraction of GWAS data and statistical genetic analysis; 9) Coordinate and fund retrieval of stored biospecimens for selected assays; 10) Coordinate the close-out of the study. B. Project Plan Within 30 calendar days following contract award, the Contractor shall submit a project plan. This plan shall include the following: the final sites for the WHIMS-ECHO data collection, projected recruitment goals for each site, the racial/ethnic breakdown for the projected recruitment, and an outline of issues requiring further discussion. The plan shall also include the current research protocol and the current Manual of Procedures. A conference call shall be held within one (1) week of submission to review the project plan and operational directions, problems and solutions, and project status. C. Specific Requirements 1. Contacting and Scheduling Participants. The Contractor shall develop or adapt informed consent materials for continued participation in WHIMS-ECHO. The Contractor shall obtain appropriate institutional review board approvals from participating sites and shall provide copies of such to the COR. The Contractor shall identify, recruit, and obtain informed consent for eligible WHIMS-ECHO participants from ongoing study participants. Participant recruitment shall be conducted so as to ensure minority representation. The Contractor or their designate at the participating sites shall schedule enrolled participants. 2. Telephone Assessment Battery. Data collection and scoring shall be performed by trained and certified test administrators, as specified in the manual of procedures. The Contractor shall advise the COR in writing of any modifications to the telephone assessment battery. The initial and modified procedures shall be approved prior to implementation in writing by the COR. The telephone assessment battery shall consist of the following procedures: • Telephone Interview for Cognitive Status-modified (TICS-m) • East Boston Memory Test (EBMT) • Oral Trail Making Test (OTMT) - Parts A & B • Verbal Fluency-Animals (VF-A) • Digit Span Test (DST) • California Verbal Learning Test (Immediate Recall) • Dementia Questionnaire (DQ) • Geriatric Depression Scale (GDS) - Short Form • Insomnia Rating 3. Quality Control. All measures shall be administered and scored according to standardized procedures, as specified in the manual of procedures. All tests shall be double-scored and entered, where appropriate. Acceptable data shall include complete assessments with minimal missing data and free of scoring and entry errors. • The contractor shall develop and implement a Quality Assurance/Quality Control (QA/QC) plan to standardize contract research processes to ensure that the conduct of the assessments and all data generated meet all regulatory standards. This plan shall include standard operating procedures for establishing and maintaining the QA/QC process. • Submit a draft of this plan within ninety (90) calendar days following contract award. • The COR will provide comments to the Contractor within two (2) weeks of receipt of the draft plan. • Submit a final plan that incorporates the COR's comments within two (2) weeks after comments are received. 4. Monitoring. The Contractor shall maintain training and certification of testers administering the telephone assessment battery and develop and monitor procedures for determination of diagnostic information. 5. Data. The data to be generated by this contract are the raw and scored test results of the WHIMS-ECHO assessments and shall include demographic variables, health status information, treatment status or any other information necessary for interpretation of the cognitive data. All data shall be maintained by the Contractor under controlled and secure conditions for the duration of the contract period. Upon completion of the contract, all data collected prospectively under this contract will remain the property of the NIH. The Contractor shall: • Accumulate and maintain appropriate data files. • Maintain confidentiality and security of data files. • Revise current data collection forms as necessary. • Collect, edit, store, analyze and report on WHIMS data. • Prepare limited access datasets. • Provide frozen data files and documentation at the request of and as directed by the COR and also at the contract expiration date. • Provide a plan for data sharing. • Maintain records of biological samples retrieved under the contract, including participant identifiers, assays performed, and results of assays. 6. Data Archiving and Transfer. The Contractor shall be responsible for archiving and back-ups of primary data and electronic transfer of diagnostic and telephone assessment data to the NIA, where a copy of the data shall be stored on the NIA servers and maintained by the NIA Intramural Research Program IT group. Annual transmission of data to NIA shall be performed in a format compatible with SAS statistical analysis software. 7. Manuscripts and other scientific activities. The Contractor shall • Provide appropriate methods of analysis and presentation of data collected. • Perform data analysis and coordinate the preparation and writing of scientific reports and manuscripts for publications, in collaboration with other study investigators, the WHI CCC, and the COR. • Coordinate the dissemination of WHIMS findings with the NIH and WHI Steering Committee. The Contractor shall provide copies of manuscripts for publication based upon data generated under this contract to the COR and obtain written or email authorization from the COR before submitting manuscripts for publication. Manuscripts shall be submitted to the COR fourteen (14) calendar days prior to submission for publication. Support from the Government contract shall be acknowledged in publications. The Contractor shall not publish, present or disseminate any information from work performed under this contract without submission of the materials to the COR for review. REPORTING REQUIREMENTS AND DELIVERABLES: The following reports will be required: (1) Project Pan; (2) Semi-Annual Technical Report; (3) Annual Progress Reports; (4) Final Report; (5) Data; (6) Report of Unexpected Adverse Event; and (7) Contract Closeout documents. ANTICIPATED PERIOD OF PERFORMANCE: The estimated month of award is July 2016 with an anticipated period of performance of five (5) years. OTHER IMPORTANT CONSIDERATIONS: The North American Industry Classification System (NAICS) Code 541712 with a size standard of 500 employees. CAPABILITY STATEMENT/INFORMATION SOUGHT: NIA is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS: Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than September 24, 2015 at 3:00 PM (EST); (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to haynest@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Tawanda Haynes-Brown, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) 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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