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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Early Stage Health Technology Assessment for Precision Biomarkers in Oral Health and Systems Medicine</title>
<author><name sortKey="Steuten, Lotte M G" sort="Steuten, Lotte M G" uniqKey="Steuten L" first="Lotte M. G." last="Steuten">Lotte M. G. Steuten</name>
<affiliation><nlm:aff id="aff1"></nlm:aff>
</affiliation>
<affiliation><nlm:aff id="aff2"></nlm:aff>
</affiliation>
<affiliation><nlm:aff id="aff3"></nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">26760958</idno>
<idno type="pmc">4739424</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4739424</idno>
<idno type="RBID">PMC:4739424</idno>
<idno type="doi">10.1089/omi.2015.0174</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">000784</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Early Stage Health Technology Assessment for Precision Biomarkers in Oral Health and Systems Medicine</title>
<author><name sortKey="Steuten, Lotte M G" sort="Steuten, Lotte M G" uniqKey="Steuten L" first="Lotte M. G." last="Steuten">Lotte M. G. Steuten</name>
<affiliation><nlm:aff id="aff1"></nlm:aff>
</affiliation>
<affiliation><nlm:aff id="aff2"></nlm:aff>
</affiliation>
<affiliation><nlm:aff id="aff3"></nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">OMICS : a Journal of Integrative Biology</title>
<idno type="ISSN">1536-2310</idno>
<idno type="eISSN">1557-8100</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
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</teiHeader>
<front><div type="abstract" xml:lang="en"><title>Abstract</title>
<p>Health technology assessment (HTA) is a crucial science that influences the responsible and evidence-based transition of new discoveries from laboratory to applications in the clinic and society. HTA has recently moved “upstream” so as to assess technologies from their onset at their discovery, design, or planning phase. Biomarker research is relatively recent in oral health, but growing rapidly with investments made to advance dentistry and oral health and importantly, to build effective bridges between oral health and systems medicine since what happens in oral health affects systems pathophysiology, and vice versa. This article offers a synthesis of the latest trends and approaches in early phase HTA, with a view to near future applications in oral health, systems medicine, and biomarker-guided precision medicine. In brief, this review underscores that demonstrating health outcomes of biomarkers and next-generation diagnostics is particularly challenging because they do not always influence long-term outcomes directly, but rather impact subsequent care processes. Biomarker testing costs are typically less of a barrier to uptake in practice than the biomarker's impact on longer term health outcomes. As a single biomarker or next-generation diagnostic in oral health can inform decisions about numerous downstream diagnosis-treatment combinations, early stage “upstream” HTA is crucial in prioritizing the most valuable diagnostic applications to pursue first. For the vast array of oral health biomarkers currently developed, early HTA is necessary to timely and iteratively assess their comparative effectiveness and anticipate the inevitable questions about value for money from regulators and payers.</p>
</div>
</front>
</TEI>
<pmc article-type="review-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">OMICS</journal-id>
<journal-id journal-id-type="iso-abbrev">OMICS</journal-id>
<journal-id journal-id-type="publisher-id">omi</journal-id>
<journal-title-group><journal-title>OMICS : a Journal of Integrative Biology</journal-title>
</journal-title-group>
<issn pub-type="ppub">1536-2310</issn>
<issn pub-type="epub">1557-8100</issn>
<publisher><publisher-name>Mary Ann Liebert, Inc.</publisher-name>
<publisher-loc>140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26760958</article-id>
<article-id pub-id-type="pmc">4739424</article-id>
<article-id pub-id-type="publisher-id">10.1089/omi.2015.0174</article-id>
<article-id pub-id-type="doi">10.1089/omi.2015.0174</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Review Articles</subject>
</subj-group>
</article-categories>
<title-group><article-title>Early Stage Health Technology Assessment for Precision Biomarkers in Oral Health and Systems Medicine</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Steuten</surname>
<given-names>Lotte M.G.</given-names>
</name>
<xref ref-type="aff" rid="aff1"><sup>1,</sup>
</xref>
<xref ref-type="aff" rid="aff2"><sup>2,</sup>
</xref>
<xref ref-type="aff" rid="aff3"><sup>3</sup>
</xref>
</contrib>
<aff id="aff1"><label><sup>1</sup>
</label>
Fred Hutchinson Cancer Research Center,<institution>Hutchinson Institute for Cancer Outcomes Research</institution>
, Seattle, Washington,<country>United States</country>
.</aff>
<aff id="aff2"><label><sup>2</sup>
</label>
School of Pharmacy,<institution>University of Washington</institution>
, Seattle, Washington,<country>United States</country>
.</aff>
<aff id="aff3"><label><sup>3</sup>
</label>
<institution>Panaxea bv</institution>
, Enschede, The<country>Netherlands</country>
.</aff>
</contrib-group>
<author-notes><corresp><addr-line>Address correspondence to:</addr-line>
<addr-line><italic>Lotte M.G. Steuten, PhD</italic>
</addr-line>
<addr-line><italic>Fred Hutchinson Cancer Research Center</italic>
</addr-line>
<institution><italic>Hutchinson Institute for Cancer Outcomes Research</italic>
</institution>
<addr-line><italic>1110 Fairview Avenue N</italic>
</addr-line>
<addr-line><italic>Seattle, WA 98109</italic>
</addr-line>
<country>United States</country>
<addr-line>or</addr-line>
<addr-line><italic>Panaxea bv</italic>
</addr-line>
<addr-line><italic>Hengelosestraat 221</italic>
</addr-line>
<addr-line><italic>Enschede 7521 AC</italic>
</addr-line>
<country>The Netherlands</country>
<break></break>
<italic>E-mail:</italic>
<email xlink:href="mailto:lotte.steuten@panaxea.eu">lotte.steuten@panaxea.eu</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><day>01</day>
<month>1</month>
<year>2016</year>
<pmc-comment>string-date: January 2016</pmc-comment>
</pub-date>
<volume>20</volume>
<issue>1</issue>
<fpage>30</fpage>
<lpage>35</lpage>
<permissions><copyright-statement>Copyright 2016, Mary Ann Liebert, Inc.</copyright-statement>
<copyright-year>2016</copyright-year>
</permissions>
<self-uri content-type="pdf" xlink:type="simple" xlink:href="omi.2015.0174.pdf"></self-uri>
<abstract><title>Abstract</title>
<p>Health technology assessment (HTA) is a crucial science that influences the responsible and evidence-based transition of new discoveries from laboratory to applications in the clinic and society. HTA has recently moved “upstream” so as to assess technologies from their onset at their discovery, design, or planning phase. Biomarker research is relatively recent in oral health, but growing rapidly with investments made to advance dentistry and oral health and importantly, to build effective bridges between oral health and systems medicine since what happens in oral health affects systems pathophysiology, and vice versa. This article offers a synthesis of the latest trends and approaches in early phase HTA, with a view to near future applications in oral health, systems medicine, and biomarker-guided precision medicine. In brief, this review underscores that demonstrating health outcomes of biomarkers and next-generation diagnostics is particularly challenging because they do not always influence long-term outcomes directly, but rather impact subsequent care processes. Biomarker testing costs are typically less of a barrier to uptake in practice than the biomarker's impact on longer term health outcomes. As a single biomarker or next-generation diagnostic in oral health can inform decisions about numerous downstream diagnosis-treatment combinations, early stage “upstream” HTA is crucial in prioritizing the most valuable diagnostic applications to pursue first. For the vast array of oral health biomarkers currently developed, early HTA is necessary to timely and iteratively assess their comparative effectiveness and anticipate the inevitable questions about value for money from regulators and payers.</p>
</abstract>
<counts><table-count count="1"></table-count>
<ref-count count="27"></ref-count>
<page-count count="6"></page-count>
</counts>
</article-meta>
</front>
</pmc>
</record>
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