FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2783021184> ?p ?o ?g. }

• W2783021184 abstract "The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort.To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule.We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future." @default.
• W2783021184 created "2018-01-26" @default.
• W2783021184 creator A5040295464 @default.
• W2783021184 creator A5052888379 @default.
• W2783021184 creator A5065297960 @default.
• W2783021184 creator A5077263241 @default.
• W2783021184 creator A5081633297 @default.
• W2783021184 date "2018-01-08" @default.
• W2783021184 modified "2023-10-11" @default.
• W2783021184 title "Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product" @default.
• W2783021184 cites W1931781407 @default.
• W2783021184 cites W1974084970 @default.
• W2783021184 cites W1980043956 @default.
• W2783021184 cites W1990387125 @default.
• W2783021184 cites W2023570102 @default.
• W2783021184 cites W2043555090 @default.
• W2783021184 cites W2084061645 @default.
• W2783021184 cites W2097581830 @default.
• W2783021184 cites W2116436356 @default.
• W2783021184 cites W2128659393 @default.
• W2783021184 cites W2145212823 @default.
• W2783021184 cites W2166293007 @default.
• W2783021184 cites W2295526245 @default.
• W2783021184 cites W2320742816 @default.
• W2783021184 cites W2343789768 @default.
• W2783021184 cites W2400414480 @default.
• W2783021184 cites W2462315898 @default.
• W2783021184 cites W2549509746 @default.
• W2783021184 cites W2738695267 @default.
• W2783021184 doi "https://doi.org/10.1186/s13063-017-2432-3" @default.
• W2783021184 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/5759253" @default.
• W2783021184 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/29310706" @default.
• W2783021184 hasPublicationYear "2018" @default.
• W2783021184 type Work @default.
• W2783021184 sameAs 2783021184 @default.
• W2783021184 citedByCount "8" @default.
• W2783021184 countsByYear W27830211842019 @default.
• W2783021184 countsByYear W27830211842021 @default.
• W2783021184 countsByYear W27830211842022 @default.
• W2783021184 countsByYear W27830211842023 @default.
• W2783021184 crossrefType "journal-article" @default.
• W2783021184 hasAuthorship W2783021184A5040295464 @default.
• W2783021184 hasAuthorship W2783021184A5052888379 @default.
• W2783021184 hasAuthorship W2783021184A5065297960 @default.
• W2783021184 hasAuthorship W2783021184A5077263241 @default.
• W2783021184 hasAuthorship W2783021184A5081633297 @default.
• W2783021184 hasBestOaLocation W27830211841 @default.
• W2783021184 hasConcept C141071460 @default.
• W2783021184 hasConcept C142724271 @default.
• W2783021184 hasConcept C144024400 @default.
• W2783021184 hasConcept C148482608 @default.
• W2783021184 hasConcept C168563851 @default.
• W2783021184 hasConcept C19527891 @default.
• W2783021184 hasConcept C204787440 @default.
• W2783021184 hasConcept C2779318504 @default.
• W2783021184 hasConcept C36289849 @default.
• W2783021184 hasConcept C512399662 @default.
• W2783021184 hasConcept C535046627 @default.
• W2783021184 hasConcept C68122502 @default.
• W2783021184 hasConcept C71924100 @default.
• W2783021184 hasConcept C72563966 @default.
• W2783021184 hasConceptScore W2783021184C141071460 @default.
• W2783021184 hasConceptScore W2783021184C142724271 @default.
• W2783021184 hasConceptScore W2783021184C144024400 @default.
• W2783021184 hasConceptScore W2783021184C148482608 @default.
• W2783021184 hasConceptScore W2783021184C168563851 @default.
• W2783021184 hasConceptScore W2783021184C19527891 @default.
• W2783021184 hasConceptScore W2783021184C204787440 @default.
• W2783021184 hasConceptScore W2783021184C2779318504 @default.
• W2783021184 hasConceptScore W2783021184C36289849 @default.
• W2783021184 hasConceptScore W2783021184C512399662 @default.
• W2783021184 hasConceptScore W2783021184C535046627 @default.
• W2783021184 hasConceptScore W2783021184C68122502 @default.
• W2783021184 hasConceptScore W2783021184C71924100 @default.
• W2783021184 hasConceptScore W2783021184C72563966 @default.
• W2783021184 hasFunder F4320334659 @default.
• W2783021184 hasIssue "1" @default.
• W2783021184 hasLocation W27830211841 @default.
• W2783021184 hasLocation W27830211842 @default.
• W2783021184 hasLocation W27830211843 @default.
• W2783021184 hasLocation W27830211844 @default.
• W2783021184 hasLocation W27830211845 @default.
• W2783021184 hasOpenAccess W2783021184 @default.
• W2783021184 hasPrimaryLocation W27830211841 @default.
• W2783021184 hasRelatedWork W1528988984 @default.
• W2783021184 hasRelatedWork W1976884228 @default.
• W2783021184 hasRelatedWork W1980043956 @default.
• W2783021184 hasRelatedWork W1996947321 @default.
• W2783021184 hasRelatedWork W2000082121 @default.
• W2783021184 hasRelatedWork W2004225182 @default.
• W2783021184 hasRelatedWork W2020316895 @default.
• W2783021184 hasRelatedWork W2021316447 @default.
• W2783021184 hasRelatedWork W2042378780 @default.
• W2783021184 hasRelatedWork W2109993319 @default.
• W2783021184 hasRelatedWork W2124211545 @default.
• W2783021184 hasRelatedWork W2143386124 @default.
• W2783021184 hasRelatedWork W2150000565 @default.
• W2783021184 hasRelatedWork W2193089370 @default.
• W2783021184 hasRelatedWork W2264823119 @default.
• W2783021184 hasRelatedWork W2313980252 @default.

• next