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Causal inferences a...
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Johansson, PerUppsala universitet,Institutet för arbetsmarknads- och utbildningspolitisk utvärdering (IFAU),Statistiska institutionen,Hälsoekonomi,Tsinghua University, Beijing, China
(författare)
Causal inferences and real-world evidence : A comparative effectiveness evaluation of abiraterone acetate against enzalutamide
- Artikel/kapitelEngelska2023
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Public Library of Science (PLoS),2023
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LIBRIS-ID:oai:DiVA.org:uu-504821
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-504821URI
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https://doi.org/10.1371/journal.pone.0293000DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:art swepub-publicationtype
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Regulatory authorities are recognizing the need for real-world evidence (RWE) as a complement to randomized controlled trials in the approval of drugs. However, RWE needs to be fit for regulatory purposes. There is an ongoing discussion regarding whether pre-publication of a protocol on appropriate repositories, e.g. ClinicalTrials.gov, would increase the quality of RWE or not. This paper illustrates that an observational study based on a pre-published protocol can entail the same level of detail as a protocol for a randomized experiment. The strategy is exemplified by designing a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice. These two cancer drugs are prescribed to patients with advanced prostate cancer. Two complementary designs, including pre-analysis plans, were published before data on outcomes and proxy-outcomes were obtained. The underlying assumptions are assessed and both analyses show an increased mortality risk from being prescribed abiraterone acetate compared to enzalutamide.
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Jonéus, PaulinaUppsala universitet,Statistiska institutionen(Swepub:uu)paujo877
(författare)
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Langenskiöld, Sophie,1968-Uppsala universitet,Hälsoekonomi(Swepub:uu)sopla565
(författare)
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Uppsala universitetInstitutet för arbetsmarknads- och utbildningspolitisk utvärdering (IFAU)
(creator_code:org_t)
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Ingår i:PLOS ONE: Public Library of Science (PLoS)18:101932-6203
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