FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3033718308> ?p ?o ?g. }

• W3033718308 abstract "ABSTRACT In this study, we explored the feasibility of using real-world data (RWD) from a large clinical research network to simulate real-world clinical trials of Alzheimer’s disease (AD). The target trial (i.e., NCT00478205 ) is a Phase III double-blind, parallel-group trial that compared the 23 mg donepezil sustained release with the 10 mg donepezil immediate release formulation in patients with moderate to severe AD. We followed the target trial’s study protocol to identify the study population, treatment regimen assignments, and outcome assessments, and to set up a number of different simulation scenarios and parameters. We considered two main scenarios: (1) a one-arm simulation: simulating a standard-of-care arm that can serve as an external control arm; and (2) a two-arm simulation: simulating both intervention and control arms with proper patient matching algorithms for comparative effectiveness analysis. In the two-arm simulation scenario, we used propensity score matching controlling for baseline characteristics to simulate the randomization process. In the two-arm simulation, higher SAE rates were observed in the simulated trials than the rates reported in original trial, and a higher SAE rate was observed in the 23mg arm than the 10 mg standard-of-care arm. In the one-arm simulation scenario, similar estimates of SAE rates were observed when proportional sampling was used to control demographic variables. In conclusion, trial simulation using RWD is feasible in this example of AD trial in terms of safety evaluation. Trial simulation using RWD could be a valuable tool for post-market comparative effectiveness studies and for informing future trials’ design. Nevertheless, such approach may be limited, for example, by the availability of RWD that matches the target trials of interest, and further investigations are warranted." @default.
• W3033718308 created "2020-06-12" @default.
• W3033718308 creator A5020154592 @default.
• W3033718308 creator A5030951014 @default.
• W3033718308 creator A5039419132 @default.
• W3033718308 creator A5039891212 @default.
• W3033718308 creator A5047567293 @default.
• W3033718308 creator A5052505769 @default.
• W3033718308 creator A5064885745 @default.
• W3033718308 creator A5074392705 @default.
• W3033718308 creator A5076610873 @default.
• W3033718308 date "2020-06-05" @default.
• W3033718308 modified "2023-10-14" @default.
• W3033718308 title "Exploring the Feasibility of Using Real-World Data from a Large Clinical Data Research Network to Simulate Clinical Trials of Alzheimer’s Disease" @default.
• W3033718308 cites W1480745369 @default.
• W3033718308 cites W1971463294 @default.
• W3033718308 cites W1994765376 @default.
• W3033718308 cites W2038430307 @default.
• W3033718308 cites W2048483249 @default.
• W3033718308 cites W2055577486 @default.
• W3033718308 cites W2076764901 @default.
• W3033718308 cites W2112662877 @default.
• W3033718308 cites W2114076752 @default.
• W3033718308 cites W2114938072 @default.
• W3033718308 cites W2136975742 @default.
• W3033718308 cites W2141158065 @default.
• W3033718308 cites W2151899701 @default.
• W3033718308 cites W2263715254 @default.
• W3033718308 cites W2298338128 @default.
• W3033718308 cites W2588520113 @default.
• W3033718308 cites W2765619636 @default.
• W3033718308 cites W2889769391 @default.
• W3033718308 cites W2904021770 @default.
• W3033718308 cites W2942833519 @default.
• W3033718308 cites W3022623176 @default.
• W3033718308 cites W3129758832 @default.
• W3033718308 cites W892316021 @default.
• W3033718308 doi "https://doi.org/10.1101/2020.06.03.20121491" @default.
• W3033718308 hasPublicationYear "2020" @default.
• W3033718308 type Work @default.
• W3033718308 sameAs 3033718308 @default.
• W3033718308 citedByCount "0" @default.
• W3033718308 crossrefType "posted-content" @default.
• W3033718308 hasAuthorship W3033718308A5020154592 @default.
• W3033718308 hasAuthorship W3033718308A5030951014 @default.
• W3033718308 hasAuthorship W3033718308A5039419132 @default.
• W3033718308 hasAuthorship W3033718308A5039891212 @default.
• W3033718308 hasAuthorship W3033718308A5047567293 @default.
• W3033718308 hasAuthorship W3033718308A5052505769 @default.
• W3033718308 hasAuthorship W3033718308A5064885745 @default.
• W3033718308 hasAuthorship W3033718308A5074392705 @default.
• W3033718308 hasAuthorship W3033718308A5076610873 @default.
• W3033718308 hasBestOaLocation W30337183081 @default.
• W3033718308 hasConcept C105795698 @default.
• W3033718308 hasConcept C126322002 @default.
• W3033718308 hasConcept C142724271 @default.
• W3033718308 hasConcept C165064840 @default.
• W3033718308 hasConcept C1862650 @default.
• W3033718308 hasConcept C204243189 @default.
• W3033718308 hasConcept C204787440 @default.
• W3033718308 hasConcept C2779134260 @default.
• W3033718308 hasConcept C2779483572 @default.
• W3033718308 hasConcept C2780385302 @default.
• W3033718308 hasConcept C2780904820 @default.
• W3033718308 hasConcept C2781413609 @default.
• W3033718308 hasConcept C2908647359 @default.
• W3033718308 hasConcept C33923547 @default.
• W3033718308 hasConcept C41008148 @default.
• W3033718308 hasConcept C44154836 @default.
• W3033718308 hasConcept C535046627 @default.
• W3033718308 hasConcept C71924100 @default.
• W3033718308 hasConcept C99454951 @default.
• W3033718308 hasConcept C99508421 @default.
• W3033718308 hasConceptScore W3033718308C105795698 @default.
• W3033718308 hasConceptScore W3033718308C126322002 @default.
• W3033718308 hasConceptScore W3033718308C142724271 @default.
• W3033718308 hasConceptScore W3033718308C165064840 @default.
• W3033718308 hasConceptScore W3033718308C1862650 @default.
• W3033718308 hasConceptScore W3033718308C204243189 @default.
• W3033718308 hasConceptScore W3033718308C204787440 @default.
• W3033718308 hasConceptScore W3033718308C2779134260 @default.
• W3033718308 hasConceptScore W3033718308C2779483572 @default.
• W3033718308 hasConceptScore W3033718308C2780385302 @default.
• W3033718308 hasConceptScore W3033718308C2780904820 @default.
• W3033718308 hasConceptScore W3033718308C2781413609 @default.
• W3033718308 hasConceptScore W3033718308C2908647359 @default.
• W3033718308 hasConceptScore W3033718308C33923547 @default.
• W3033718308 hasConceptScore W3033718308C41008148 @default.
• W3033718308 hasConceptScore W3033718308C44154836 @default.
• W3033718308 hasConceptScore W3033718308C535046627 @default.
• W3033718308 hasConceptScore W3033718308C71924100 @default.
• W3033718308 hasConceptScore W3033718308C99454951 @default.
• W3033718308 hasConceptScore W3033718308C99508421 @default.
• W3033718308 hasLocation W30337183081 @default.
• W3033718308 hasLocation W30337183082 @default.
• W3033718308 hasOpenAccess W3033718308 @default.
• W3033718308 hasPrimaryLocation W30337183081 @default.
• W3033718308 hasRelatedWork W3467597 @default.
• W3033718308 hasRelatedWork W3649688 @default.
• W3033718308 hasRelatedWork W4799399 @default.

• next