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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 08, 2015 FBO #5098
SOLICITATION NOTICE

A -- The Women’s Health Initiative Memory Study (WHIMS) Suite of Studies

Notice Date

11/6/2015
 

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 Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
 

ZIP Code

20892-9661
 

Solicitation Number

HHS-NIH-NIDA(AG)-RFP-15-006
 

Archive Date

12/20/2015
 

Point of Contact

Kim Stapleton, Phone: (301)4433775, Yvette Brown, Phone: 301 443-2696
 

E-Mail Address

kimberlee.stapleton@nih.gov, Yvette.Brown@nih.gov
(kimberlee.stapleton@nih.gov, Yvette.Brown@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

PRESOLICITATION NOTICE The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate under authority of FAR 6.302-1, on a non competitive, sole source basis, with Wake Forest University, entitled "The Women's Health Initiative Memory Study (WHIMS) Suite of Studies". This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This effort will be for five years. The WHIMS Suite of Studies is in accordance with the authority 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. 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. Wake Forest University is uniquely qualified to conduct these studies as the WHIMS study began at the University with private funding and Wake Forest has developed and maintained the cohorts and procedures in the initial assessment periods. The raw data resulting from the initial contract period of this study under private funding are owned by Wake Forest University and are not publicly available or transferable. These initial data include the information at pre-treatment baseline evaluation (before any hormone or other intervention) that are necessary to examine the earliest risk and protective factors that may be associated with cognitive impairment, including dementia, and cognitive resilience as long as 20 years later. It is not possible for another vendor to perform the follow-on study because the required data collected at study baseline are owned by Wake Forest University and are not transferable. In addition, Wake Forest University has permission to conduct the WHIMS study as an ancillary study to the WHI parent study and obtained informed consent from participants at the initiation of the study. Neither is transferable and a new contractor would have to submit a new request for an ancillary study to WHI and would have to reconsent participants, resulting in a 6 to 9 month delay of the study and added costs. Additionally, these baseline data will be used to identify risk and protective factors for cognitive decline and impairment more than 20 years later in relation to the HT interventions administered through 2002 and 2004 for combination HT and CEE-Alone, respectively. It is not possible to repeat this study as it is no longer ethical to conduct a large scale study investigating effects of these hormonal treatments on cognition in older postmenopausal hormone therapy because the WHI studies showed that the health risks of these treatments in older women exceeded the benefits. The FDA now recommends HT use for treatment of menopausal symptoms for the shortest possible duration. Thus, the WHIMS study, including data collected under the initial private funding to Wake Forest University, provides a unique opportunity to investigate risk and protective factors on long-term cognitive outcomes within the context of a randomized clinical trial of HT. 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. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-RDSS-15-006 and HHS-NIH-NIDA(AG)-SBSS-15-006. All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-RFP-15-006/listing.html)
 

Place of Performance

Address: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States

Zip Code: 27157
 

Record

SN03940928-W 20151108/151106234411-422d06db84a1d720438f8c8a82e18b15 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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