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6 The Women's Health Initiative: Lessons for the Population Study of Biomarkers--Robert B. Wallace
6 The Women's Health Initiative: Lessons for the Population Study of Biomarkers--Robert B. Wallace
Pages 136-148
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From page 136... ...
In addition, I address some of the social and organizational aspects of managing biomarker studies and study investigators, as well as the large data sets, specimen collections, and scientific applications.
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From page 137... ...
Three of the most important were not being able to spend the time undergoing the trials' rigors; unwillingness to be randomized with respect to the use of hormonal therapy; and having too low a percentage of dietary fat calories, making them ineligible for the dietary modification trial. Participants in the clinical trials as well as the OS had the same, extensive baseline data collection, including medical history, risk factors for important chronic illnesses, social and behavioral characteristics, mental health characteristics, and diet and dietary supplement use.
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From page 138... ...
The specimens collected in WHI continue to be used for many scientific purposes, under the heading of "ancillary studies," which are described below. SPECIMEN ACQUISITION AND THE INSTITUTIONAL REVIEW BOARD Although many issues regarding the ethics of specimen collection are beyond the scope of this discussion, some issues and situations concerning the WHI experience are worthy of note.
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From page 139... ...
Other biomarker applications, such as explaining WHI findings, pursuing industrial applications, and joining collaborative biospecimen groups, are discussed below. In addition, a major disposition for collected specimens is WHI investigator-initiated ancillary studies, those not part of the original WHI mission but that are deemed to be high-quality science and to have relevance to women's health issues.
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From page 140... ...
. The same principles would be true for other types of biomarkers in population studies, such as trace elements in bodily fluids, microbiological specimens, or micronutrients (Wild, Andersson, O'Brien, Wilson, and Woods, 2001)
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From page 141... ...
That is, most WHI investigators think it is important to provide the findings from local ancillary studies to the WHI data bank back for further study after the primary scientific reports have become public, allowing other investigators to use the biomarker determinations for other hypotheses and avoiding duplication of cost or accelerated specimen depletion. In the longer term, NIH policies are likely to demand that the data become available from large studies such as WHI, but rapid archiving of information will accelerate this scientific process.
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From page 142... ...
WHI has received requests for data from persons outside the study, and the usual issues of maintaining confidentiality as well as allowing investigators to complete and publish their original studies are important here. Biomarker studies in general may have special issues of confidentiality, particularly for unique genetic coding sequences, and this must be considered when contemplating the release of such information.
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From page 143... ...
Laboratory investigations are being considered to explore other adverse effects that occurred with WHI interventions, such as an increased risk of dementia associated with hormone therapy (Shumaker et al., 2003) and a 17 percent increased risk of kidney stones associated among women taking calcium and vitamin D supplements.
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From page 144... ...
Work on this partnership activity is continuing, and the possibility of defining genetic and other molecular risk factors for the hormone-related adverse effects may be important in the future. ADDITIONAL APPLICATIONS FOR BIOMARKER STUDIES IN WHI Participation in Large Scientific Consortia Emphasizing Biomarkers In addition to the priority dispositions of biomarker specimens generated by WHI leadership and investigators, larger population studies and clinical trials should consider partnering with collaborative studies that pool individual study data and findings, and thus have the capacity to explore important scientific questions that no one study can attain.
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From page 145... ...
It may be possible to use populations such as in WHI to explore health disparities, particularly those that may be manifest in biomarker determinations. With the range of ethnic and racial groups represented, the substantial representation of both rural and urban women, and the variation in health and functional status, this study in longitudinal context may provide substantial insight into health outcomes related to biological measurement.
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From page 146... ...
STRENGTHS AND WEAKNESSES OF BIOMARKERS STUDIES USING CLINCAL TRIAL POPULATIONS It is important to note the issues that population scientists face when attempting to study clinical trial populations such as WHI and its companion observational cohort. There are many strengths to such an approach, including the very large sample size, the broad age distribution, the large number of minority participants, the broad range of social and behavioral measures available for study, the large and multidisciplinary group of investigators who can provide collaboration and consultation, the exquisitely documented nature of many of the health outcomes, including those that are less common and not part of the initial study design or primary outcomes, and the advanced planning for specimen storage and retrieval.
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From page 147... ...
Other potential impediments include differing propensities of the 42 IRBs to allow ancillary studies and the potential IRB demand for reconsenting of participants for new, previously unplanned determinations on archived biological specimens. In addition, the blood or blood components for specific participants may be dwindling or not available, and that may thwart certain types of studies of participants with specific characteristics.
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From page 148... ...
Controlled Clinical Trials, 19, 61-109. Writing Group for the Women's Health Initiative.
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