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dc.date.accessioned2020-05-17T18:09:07Z
dc.date.available2020-05-17T18:09:07Z
dc.date.created2019-06-20T15:24:29Z
dc.date.issued2019
dc.identifier.citationKulle, Bettina Støer, Nathalie Charlotte Martinsen, Jan Ivar Ursin, Giske Weiderpass, Elisabete Thoresen, G. Hege Debernard, Karen A. Boldingh Karlstad, Øystein Pottegard, Anton Friis, Søren . Identification of potential carcinogenic and chemopreventive effects of prescription drugs: A protocol for a Norwegian registry-based study. BMJ Open. 2019, 9:e028504(4), 1-7
dc.identifier.urihttp://hdl.handle.net/10852/75843
dc.description.abstractSurveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations.Methods and analysisThe main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case–control design including all adult (~200 000) incident cancer cases within the age-range 18–85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions’ daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use–cancer-risk associations.Ethics and disseminationThe study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.
dc.languageEN
dc.publisherBMJ Publishing Group
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.titleIdentification of potential carcinogenic and chemopreventive effects of prescription drugs: A protocol for a Norwegian registry-based study
dc.typeJournal article
dc.creator.authorKulle, Bettina
dc.creator.authorStøer, Nathalie Charlotte
dc.creator.authorMartinsen, Jan Ivar
dc.creator.authorUrsin, Giske
dc.creator.authorWeiderpass, Elisabete
dc.creator.authorThoresen, G. Hege
dc.creator.authorDebernard, Karen A. Boldingh
dc.creator.authorKarlstad, Øystein
dc.creator.authorPottegard, Anton
dc.creator.authorFriis, Søren
cristin.unitcode185,15,23,30
cristin.unitnameFarmakologi og farmasøytisk biovitenskap
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1
dc.identifier.cristin1706528
dc.identifier.bibliographiccitationinfo:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=BMJ Open&rft.volume=9:e028504&rft.spage=1&rft.date=2019
dc.identifier.jtitleBMJ Open
dc.identifier.volume9
dc.identifier.issue4
dc.identifier.doihttps://doi.org/10.1136/bmjopen-2018-028504
dc.identifier.urnURN:NBN:no-78954
dc.type.documentTidsskriftartikkel
dc.type.peerreviewedPeer reviewed
dc.source.issn2044-6055
dc.identifier.fulltextFulltext https://www.duo.uio.no/bitstream/handle/10852/75843/2/article70167.pdf
dc.type.versionPublishedVersion
cristin.articleide028504


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