Example: EU Clinical Trial Register - DRAFT

Owned by Heiner Oberkampf
Last updated: Jul 05, 2023 by Elisa Kendall
4 min read

Disclaimer

This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.

EU Clinical Trials Register Overview

Examples were manually built for the Clinical Trial Use cases to create Medicinal Products that had both Market Authorizations and Clinical Trial Authorizations.  Data was manually mapped from the EUCT Register website.  Each Clinical Trial had a table of information. Sections A,B, C, and D were used to map the information into the ontology.

Example Clinical Trial page for used for Fendrix:

The clinical trial's URI was set to the URI of the page containing the information.

https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002112-16/GB mapped to

    <owl:NamedIndividual rdf:about="https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002112-16/GB">
        <rdf:type rdf:resource="&idmp-mprd;ClinicalTrial"/>
    </owl:NamedIndividual>

Summary and Index:

The Summary was used for mapping the EudraCT Number field to the Eudra Clinical Trials Number which is a subclass of Registered Identifier. 

The EudraCT Number: 2014-002112-16 mapped to:

    <owl:NamedIndividual rdf:about="&idmp-euctr;EudraClinicalTrialsNumber-2014-002112-16">
        <rdf:type rdf:resource="&idmp-ra;EudraClinicalTrialsNumber"/>
        <rdfs:label>Eudra clinical trials number 2014-002112-16</rdfs:label>
        <cmns-id:identifies rdf:resource="https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002112-16/GB"/>
        <cmns-txt:hasTextValue>2014-002112-16</cmns-txt:hasTextValue>
    </owl:NamedIndividual>

The Eudra CT Number was used as part of the clinical trial authorization.

    <owl:NamedIndividual rdf:about="&idmp-euctr;ClinicalTrialAuthorization-2014-002112-16">
        <rdf:type rdf:resource="&idmp-mprd;ClinicalTrialAuthorization"/>
        <rdfs:label>clinical trial authorization 2014-002112-16</rdfs:label>
    </owl:NamedIndividual>

Protocol Information:

In the Protocol Information the title of the Trial was used to form the label of the clinical trial resulting in:

    <owl:NamedIndividual rdf:about="https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002112-16/GB">
        <rdf:type rdf:resource="&idmp-mprd;ClinicalTrial"/>
        <rdfs:label>Comparison of Fendrix and double-dose Engerix B in HIV non-responders</rdfs:label>
    </owl:NamedIndividual>

Sponsor Information:

Sponsor information was used to create the authorizing party information and make the connection from party to the clinical trial authorization. In this example Sheffield Teaching Hopstials NHS Foundation is a party that is playing the role of authorized party.

    <owl:NamedIndividual rdf:about="&idmp-euctr;SheffieldTeachingHospitalsNHSFoundation">
        <rdf:type rdf:resource="&cmns-pts;Party"/>
        <rdfs:label>Sheffield Teaching Hospitals NHS Foundation Trust</rdfs:label>
    </owl:NamedIndividual>
   
    <owl:NamedIndividual rdf:about="&idmp-euctr;SheffieldTeachingHospitalsNHSFoundationTrustAuthorizedParty">
        <rdf:type rdf:resource="&idmp-mprd;AuthorizedParty"/>
        <rdfs:label>Sheffield Teaching Hospitals NHS Foundation Trust As Authorized Party</rdfs:label>
        <cmns-pts:isPlayedBy rdf:resource="&idmp-euctr;SheffieldTeachingHospitalsNHSFoundation"/>
    </owl:NamedIndividual>

Which is used in the Clinical Trials Authorization

    <owl:NamedIndividual rdf:about="&idmp-euctr;ClinicalTrialAuthorization-2014-002112-16">
        <rdf:type rdf:resource="&idmp-mprd;ClinicalTrialAuthorization"/>
        <rdfs:label>clinical trial authorization 2014-002112-16</rdfs:label>
        <idmp-mprd:hasAuthorizedParty rdf:resource="&idmp-euctr;SheffieldTeachingHospitalsNHSFoundationTrustAuthorizedParty"/>
        <idmp-mprd:hasAuthorizingParty rdf:resource="&idmp-ra;EuropeanMedicinesAgencyAsMedicinesRegulatoryAgency"/>
        <cmns-cxtdsg:appliesTo rdf:resource="https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002112-16/GB"/>
        <cmns-cxtdsg:isApplicableIn rdf:resource="&lcc-3166-1;UnitedKingdomOfGreatBritainAndNorthernIreland"/>
    </owl:NamedIndividual>


IMP Identification

IMP Identification section was used to create the bulk of the medicinal product related assertions.  The first two sub-sections detailed whether there was a marketing authorization for the product, who was the authorization holder, the Jurisdiction of that marketing authorization, and the trade name. 

From these fields assertions for the Medicinal Product, Pharmaceutical Product, Marketing Authorization, and the medicinal product in the role of authorized medicinal product and investigational medicinal product entities were mapped.


    <owl:NamedIndividual rdf:about="&idmp-euctr;FendrixAsAuthorizedMedicinalProduct">
        <rdf:type rdf:resource="&idmp-mprd;AuthorizedMedicinalProduct"/>
        <rdfs:label>Fedrix as authorized medicinal product</rdfs:label>
        <idmp-mprd:hasAuthorization rdf:resource="&idmp-euctr;FendrixMarketingAuthorizationInEuropeanUnion"/>
        <cmns-pts:isPlayedBy rdf:resource="https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix"/>
    </owl:NamedIndividual>
   
    <owl:NamedIndividual rdf:about="&idmp-euctr;FendrixAsInvestigationalMedicinalProduct">
        <rdf:type rdf:resource="&idmp-mprd;InvestigationalMedicinalProduct"/>
        <rdfs:label>Fedrix as investigational medicinal product</rdfs:label>
        <cmns-pts:isPlayedBy rdf:resource="https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix"/>
    </owl:NamedIndividual>
   
    <owl:NamedIndividual rdf:about="&idmp-euctr;FendrixMarketingAuthorizationInEuropeanUnion">
        <rdf:type rdf:resource="&idmp-mprd;MarketingAuthorization"/>
        <rdfs:label>Fedrix Market Authorization in European Union</rdfs:label>
        <idmp-mprd:hasAuthorizedParty rdf:resource="&idmp-euctr;GlaxoSmithKlineBiologicalsAsMarketingAuthorizationHolder"/>
        <idmp-mprd:hasAuthorizingParty rdf:resource="&idmp-ra;EuropeanMedicinesAgencyAsMedicinesRegulatoryAgency"/>
        <cmns-cxtdsg:appliesTo rdf:resource="&idmp-euctr;FendrixAsAuthorizedMedicinalProduct"/>
        <cmns-cxtdsg:isApplicableIn rdf:resource="&idmp-ra;EuropeanUnionGeopoliticalEntity"/>
    </owl:NamedIndividual>
   

The rest of the IMP Identification sections detailed the ingredients of the pharmaceutical product which are connected to the Pharmaceutical product via the comprises relationship:

 
    <owl:NamedIndividual rdf:about="&idmp-euctr;FendrixPharmaceuticalProduct">
        <rdf:type rdf:resource="&idmp-mprd;PharmaceuticalProduct"/>
        <rdfs:label>Fendrix suspension For injection in pre-filled syringe PP</rdfs:label>
        <cmns-col:comprises rdf:resource="&idmp-euctr;AluminumPhosphateAsActiveIngredientRole"/>
        <cmns-col:comprises rdf:resource="&idmp-euctr;HepatitisBSurfaceAntigenAsActiveIngredient"/>
        <cmns-col:comprises rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/EuropeanUnionClinicalTrialsRegister/MonophosphorylLipidA-1-3-O-desacyl-4&apos;AsActiveIngredient"/>
    </owl:NamedIndividual>