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• WORKPACKAGES 1 |
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Theory,
Method and Conclusions |
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Workpackage 1 will
integrate workpackage 2, 3, and 4 (see Table 1): In the beginning of the
project, it elaborates a common theoretical and methodological framework
on which the empirical research in workpackage 2, 3, and 4 will be based.
In the end of the project, it will be the responsibility of workpackage
1 to summarize the empirical findings of workpackage 2, 3, and 4, to theorize
on them, and to formulate policy recommendations. |
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•
WORKPACKAGES 2 |
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To
screen or not to screen? Biomarkers for prostate cancers |
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Biomarkers are
seen as a key tool to make medical treatments more efficient through the
early detection of diseases. Workpackage 2 conducts empirical research
on biomarkers for prostate carcinoma, focusing in particular on the measurement
of prostate-specific-antigen (PSA) levels, a protein that is normally
present in the blood at very low levels but that is elevated in the presence
of a tumor in the prostate gland. Since the late 1980s prostate tumor
testing operates through the measurement of PSA level, rendering the field
of prostate cancer diagnostics an excellent example for the analysis of
a diagnostic biomarker in action. However, PSA screening is also controversial
(Linn et al. 2007), as it produces a high number of so called “false
positives”, and as the majority of men with prostate cancer will
die with but not from prostate cancer (Nature Genetics 2008). While some
take these as good arguments to drop this biomarker altogether, others
see these as reasons to search for new biomarkers that help to stratify
aggressive tumors from less aggressive ones (National Cancer Institute
2008). Therewith, the field promises rich empirical material on the development
of new biomarkers. |
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Workpackage 2 studies
biomarkers in this field, focusing in particular on the making and operation
of a PSA screening program in Tyrol, a western region in Austria, where
a screening program has been operating for almost two decades (Bartsch
et al. 2008). This site is explored against the background of Iceland,
and the United States, where the measurement of PSA levels takes place
in the absence of a centrally organized screening program. Observations
and interview data gathered in these sites are enriched through an analysis
of the “PSA screening controversies” -- scientific publications
that discuss the pros and cons of programs of this kind. Moreover, we
engage with the development of new markers in these three sites, and study
in particular how existing biomarkers interact with the development of
new ones. |
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•
WORKPACKAGES 3 |
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Governing
Therapeutics: Targeting Breast Cancers |
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Biomarkers are
strongly associated with the idea of developing more targeted drugs for
disease treatment. Workpackage 3 will look at the field of breast cancer
research, diagnostics, and therapeutics, focusing on the way in which
thera[g]nostic biomarkers become “useful” devices in clinical
medicine and transform clinical therapeutics. |
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Today, there are
no validated diagnostic biomarkers to detect breast cancer, which continues
to be based on mammograms and clinical breast exams. There are, however,
genetic tests deployed as “risk markers” to calculate the
risk of women to suffer from hereditary forms of breast cancer in the
future (King, Marks et al. 2003; Parthasarathy 2005; Parthasarathy 2007)
and thera[g]nostic tests that help shape treatment options once a breast
cancer is diagnosed. One of the best-known examples of such a thera[g]nostic
test is the practice of measuring the number of copies of a gene called
HER2: Patients suffering from breast cancer with more than one copy of
this gene are known to benefit from treatments with trastuzumab (which
is known as Herceptin). |
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Applying
our overall theoretical and methodological research framework, workpackage
3 focuses on sites of application of thera[g]nostic biomarkers for breast
cancer in Austria and Iceland, against the background of insights gained
from existing studies located in the UK (Hedgecoe 2004). Furthermore,
workpackage 3 also takes a look at new developments in breast cancer biomarker
developments, focusing in particular on deCode Genetics in Iceland. |
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Workpackage 3 cooperates
closely with workpackage 2 in order to learn whether systematic differences
exist in the governance of the development, evaluation, and application
between “diagnostic markers” and “thera[g]nostic”
markers, and whether there are systematic differences in the success of
biomarkers between “female” and “male” cancers.
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•
WORKPACKAGES 4 |
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Translating
drugs: The governance of biomarkers in China |
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Workpackage 4 focuses
on the deployment of markers in drug development in China. |
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Workpackage 4 pays
particular attention to the importance of cultural differences and the
importance of existence of specific health care systems or the lack thereof
for the transfer of biomarkers from the bench to the bedside, engaging
with the study of a biomarker operating in a country in which a specific
health care system is only just emerging. |
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Updated
24.04.2010
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