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    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Exploring the Capacity of Open, Linked Data Sources to Assess Adverse Drug Reaction Signals</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Pantelis Natsiavas</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Vassilis Koutkias</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Nicos Maglaveras</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Institute of Applied Biosciences, Centre for Research &amp; Technology Hellas</institution>
          ,
          <addr-line>Thermi, Thessaloniki</addr-line>
          ,
          <country country="GR">Greece</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Lab of Medical Informatics, Medical School, Aristotle University</institution>
          ,
          <addr-line>Thessaloniki</addr-line>
          ,
          <country country="GR">Greece</country>
        </aff>
      </contrib-group>
      <abstract>
        <p>In this work, we explore the capacity of open, linked data sources to assess adverse drug reaction (ADR) signals. Our study is based on a set of drugrelated Bio2RDF data sources and three reference datasets, containing both positive and negative ADR signals, which were used for benchmarking. We present the overall approach for this assessment and refer to some early findings based on the analysis performed so far.</p>
      </abstract>
      <kwd-group>
        <kwd>Adverse Drug Reactions</kwd>
        <kwd>signal evaluation</kwd>
        <kwd>linked data</kwd>
        <kwd>Bio2RDF</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1 Introduction</title>
      <p>
        The task of assessing potential adverse drug reaction (ADR) signals is mostly
performed manually by drug safety experts. It includes the review/analysis of
scientific literature, clinical trial data, biological properties of drugs, etc., in order to
assess causality. Linked data enable the systematic combination of various
heterogeneous data sources, and their use for drug safety has been proposed in some
studies [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ], [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. In this work, we explore the capacity of relevant Bio2RDF datasets to
assess ADR signals, using an evaluation algorithm, and discuss early findings.
      </p>
    </sec>
    <sec id="sec-2">
      <title>Material and Methods</title>
      <p>
        Bio2RDF provides access to various life-science data sources, following the
conversion of their raw data into RDF [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. In this study, we employed a set of
drugrelated data sources, namely, ClinicalTrials.gov, DrugBank, LinkedSPL and SIDER,
in order to evaluate their capacity in assessing candidate ADR signals. The evaluation
algorithm depicted in Fig. 1 is executed independently for each candidate signal
(including relevant drug and condition synonyms) across all data sources. First, we
analyzed the respective Bio2RDF data sources, in order to identify RDF properties
that semantically imply drug use indications and ADRs. We then constructed the
SPARQL queries corresponding to each step of the evaluation algorithm, which are
executed through the available Bio2RDF SPARQL endpoints. The assessment relies
on three reference datasets [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ]-[
        <xref ref-type="bibr" rid="ref6">6</xref>
        ], containing both positive and negative signals.
      </p>
    </sec>
    <sec id="sec-3">
      <title>Discussion</title>
      <p>Our first results indicate that the employed data sources can be used for signal
evaluation either independently or in conjunction. The capacity per data source varies,
depending on its purpose and the characteristics of its raw data. For example, since
SIDER contains explicit information on ADRs, it enables ADR signal confirmation
with high sensitivity. On the contrary, DrugBank which provides more general drug
information including indications for drug use, is efficient in identifying false ADR
signals with high specificity. The biggest challenge faced up to now concerns the load
capacity of the public Bio2RDF SPARQL endpoints. We currently setup endpoints
similar to Bio2RDF in a cloud infrastructure to address performance issues.
Acknowledgment. This research has been partially funded from the European
Union’s Horizon 2020 Framework Programme for Research and Innovation Action
under Grant Agreement no. 643491 (the PATHway project).</p>
    </sec>
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