FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1980501503> ?p ?o ?g. }

• W1980501503 endingPage "440" @default.
• W1980501503 startingPage "430" @default.
• W1980501503 abstract "Background Prospective trial design often occurs in the presence of ‘acceptable’ historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare." @default.
• W1980501503 created "2016-06-24" @default.
• W1980501503 creator A5002744671 @default.
• W1980501503 creator A5012243539 @default.
• W1980501503 creator A5060306466 @default.
• W1980501503 date "2013-05-20" @default.
• W1980501503 modified "2023-10-09" @default.
• W1980501503 title "Adaptive adjustment of the randomization ratio using historical control data" @default.
• W1980501503 cites W1973521570 @default.
• W1980501503 cites W1999974018 @default.
• W1980501503 cites W2000366267 @default.
• W1980501503 cites W2005415125 @default.
• W1980501503 cites W2030526274 @default.
• W1980501503 cites W2035460524 @default.
• W1980501503 cites W2041098432 @default.
• W1980501503 cites W2071150013 @default.
• W1980501503 cites W2075095321 @default.
• W1980501503 cites W2141376701 @default.
• W1980501503 cites W2149636226 @default.
• W1980501503 cites W2149734926 @default.
• W1980501503 cites W2155291829 @default.
• W1980501503 cites W2314927739 @default.
• W1980501503 cites W2795942604 @default.
• W1980501503 cites W4214512856 @default.
• W1980501503 cites W4293738259 @default.
• W1980501503 cites W4301655662 @default.
• W1980501503 cites W651652324 @default.
• W1980501503 doi "https://doi.org/10.1177/1740774513483934" @default.
• W1980501503 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/3856641" @default.
• W1980501503 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23690095" @default.
• W1980501503 hasPublicationYear "2013" @default.
• W1980501503 type Work @default.
• W1980501503 sameAs 1980501503 @default.
• W1980501503 citedByCount "88" @default.
• W1980501503 countsByYear W19805015032013 @default.
• W1980501503 countsByYear W19805015032014 @default.
• W1980501503 countsByYear W19805015032015 @default.
• W1980501503 countsByYear W19805015032016 @default.
• W1980501503 countsByYear W19805015032017 @default.
• W1980501503 countsByYear W19805015032018 @default.
• W1980501503 countsByYear W19805015032019 @default.
• W1980501503 countsByYear W19805015032020 @default.
• W1980501503 countsByYear W19805015032021 @default.
• W1980501503 countsByYear W19805015032022 @default.
• W1980501503 countsByYear W19805015032023 @default.
• W1980501503 crossrefType "journal-article" @default.
• W1980501503 hasAuthorship W1980501503A5002744671 @default.
• W1980501503 hasAuthorship W1980501503A5012243539 @default.
• W1980501503 hasAuthorship W1980501503A5060306466 @default.
• W1980501503 hasBestOaLocation W19805015032 @default.
• W1980501503 hasConcept C105795698 @default.
• W1980501503 hasConcept C107673813 @default.
• W1980501503 hasConcept C129848803 @default.
• W1980501503 hasConcept C141071460 @default.
• W1980501503 hasConcept C149782125 @default.
• W1980501503 hasConcept C154945302 @default.
• W1980501503 hasConcept C160234255 @default.
• W1980501503 hasConcept C162376815 @default.
• W1980501503 hasConcept C166957645 @default.
• W1980501503 hasConcept C168563851 @default.
• W1980501503 hasConcept C204243189 @default.
• W1980501503 hasConcept C205649164 @default.
• W1980501503 hasConcept C2776957806 @default.
• W1980501503 hasConcept C2779343474 @default.
• W1980501503 hasConcept C2908647359 @default.
• W1980501503 hasConcept C33923547 @default.
• W1980501503 hasConcept C41008148 @default.
• W1980501503 hasConcept C61943457 @default.
• W1980501503 hasConcept C71924100 @default.
• W1980501503 hasConcept C99454951 @default.
• W1980501503 hasConceptScore W1980501503C105795698 @default.
• W1980501503 hasConceptScore W1980501503C107673813 @default.
• W1980501503 hasConceptScore W1980501503C129848803 @default.
• W1980501503 hasConceptScore W1980501503C141071460 @default.
• W1980501503 hasConceptScore W1980501503C149782125 @default.
• W1980501503 hasConceptScore W1980501503C154945302 @default.
• W1980501503 hasConceptScore W1980501503C160234255 @default.
• W1980501503 hasConceptScore W1980501503C162376815 @default.
• W1980501503 hasConceptScore W1980501503C166957645 @default.
• W1980501503 hasConceptScore W1980501503C168563851 @default.
• W1980501503 hasConceptScore W1980501503C204243189 @default.
• W1980501503 hasConceptScore W1980501503C205649164 @default.
• W1980501503 hasConceptScore W1980501503C2776957806 @default.
• W1980501503 hasConceptScore W1980501503C2779343474 @default.
• W1980501503 hasConceptScore W1980501503C2908647359 @default.
• W1980501503 hasConceptScore W1980501503C33923547 @default.
• W1980501503 hasConceptScore W1980501503C41008148 @default.
• W1980501503 hasConceptScore W1980501503C61943457 @default.
• W1980501503 hasConceptScore W1980501503C71924100 @default.
• W1980501503 hasConceptScore W1980501503C99454951 @default.
• W1980501503 hasIssue "3" @default.
• W1980501503 hasLocation W19805015031 @default.
• W1980501503 hasLocation W19805015032 @default.
• W1980501503 hasLocation W19805015033 @default.
• W1980501503 hasLocation W19805015034 @default.
• W1980501503 hasOpenAccess W1980501503 @default.
• W1980501503 hasPrimaryLocation W19805015031 @default.
• W1980501503 hasRelatedWork W2000641012 @default.

• next