FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2886498839> ?p ?o ?g. }

• W2886498839 endingPage "538" @default.
• W2886498839 startingPage "531" @default.
• W2886498839 abstract "Historically, clinical trials of haemophilia with inhibitors (HwI) have been challenged by the small patient population. New approaches to clinical trial methodology and statistical modelling could potentially be used for study optimization. The aim of this work was to evaluate the impact of different trial designs and study conditions on the estimated drug potency and power, and compare traditional statistical methods with repeated time-to-event (RTTE) modelling in terms of power. Bleeding information from a clinical trial of 23 haemophilia patients with inhibitors treated on-demand was used to develop a baseline RTTE model using NONMEM. Clinical trial simulations for a hypothetical anti-haemophilic drug were performed, by adding a drug effect and a literature-derived placebo effect to the baseline RTTE model, using different trial designs (parallel-group, placebo-controlled parallel-group, crossover and placebo-controlled crossover designs) and study conditions, including sample size, study duration and doses. The precision and accuracy of the estimated drug potency (EC50) and power for different trial designs, study conditions and statistical methods (RTTE modelling, t-test and negative binomial regression) were evaluated. The developed baseline RTTE model accurately described the clinical data. The crossover designs displayed up to four-fold higher precision of the estimated EC50 and three-fold higher power relative to the parallel-group trial designs. Furthermore, RTTE modelling provided a higher power relative to the traditional statistical tests. We found that crossover designs in combination with RTTE modelling can reduce the required sample size and study duration, while ensuring high power and precise estimation of EC50, in clinical trials of HwI." @default.
• W2886498839 created "2018-08-22" @default.
• W2886498839 creator A5013955124 @default.
• W2886498839 creator A5016057087 @default.
• W2886498839 creator A5036069617 @default.
• W2886498839 creator A5065732269 @default.
• W2886498839 creator A5085695148 @default.
• W2886498839 date "2018-10-01" @default.
• W2886498839 modified "2023-09-27" @default.
• W2886498839 title "Impact of trial design on the estimation of drug potency and power in clinical trials of haemophilia with inhibitors" @default.
• W2886498839 cites W1515271279 @default.
• W2886498839 cites W1525774039 @default.
• W2886498839 cites W1567187781 @default.
• W2886498839 cites W1834132131 @default.
• W2886498839 cites W1963720875 @default.
• W2886498839 cites W1966777365 @default.
• W2886498839 cites W1967421401 @default.
• W2886498839 cites W1971463294 @default.
• W2886498839 cites W1986157879 @default.
• W2886498839 cites W1996568708 @default.
• W2886498839 cites W1997362383 @default.
• W2886498839 cites W2006467528 @default.
• W2886498839 cites W2012668456 @default.
• W2886498839 cites W2065010965 @default.
• W2886498839 cites W2066304010 @default.
• W2886498839 cites W2067873730 @default.
• W2886498839 cites W2076002415 @default.
• W2886498839 cites W2113038732 @default.
• W2886498839 cites W2113380861 @default.
• W2886498839 cites W2115579506 @default.
• W2886498839 cites W2126132750 @default.
• W2886498839 cites W2167899868 @default.
• W2886498839 cites W2321411638 @default.
• W2886498839 cites W2604693132 @default.
• W2886498839 cites W2732589685 @default.
• W2886498839 cites W2772289727 @default.
• W2886498839 doi "https://doi.org/10.1016/j.ejps.2018.07.056" @default.
• W2886498839 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30077714" @default.
• W2886498839 hasPublicationYear "2018" @default.
• W2886498839 type Work @default.
• W2886498839 sameAs 2886498839 @default.
• W2886498839 citedByCount "2" @default.
• W2886498839 countsByYear W28864988392019 @default.
• W2886498839 crossrefType "journal-article" @default.
• W2886498839 hasAuthorship W2886498839A5013955124 @default.
• W2886498839 hasAuthorship W2886498839A5016057087 @default.
• W2886498839 hasAuthorship W2886498839A5036069617 @default.
• W2886498839 hasAuthorship W2886498839A5065732269 @default.
• W2886498839 hasAuthorship W2886498839A5085695148 @default.
• W2886498839 hasConcept C105795698 @default.
• W2886498839 hasConcept C119857082 @default.
• W2886498839 hasConcept C122507166 @default.
• W2886498839 hasConcept C126322002 @default.
• W2886498839 hasConcept C129848803 @default.
• W2886498839 hasConcept C141071460 @default.
• W2886498839 hasConcept C142724271 @default.
• W2886498839 hasConcept C148482608 @default.
• W2886498839 hasConcept C204787440 @default.
• W2886498839 hasConcept C27081682 @default.
• W2886498839 hasConcept C2776239304 @default.
• W2886498839 hasConcept C2778385053 @default.
• W2886498839 hasConcept C2780367336 @default.
• W2886498839 hasConcept C2908647359 @default.
• W2886498839 hasConcept C33923547 @default.
• W2886498839 hasConcept C41008148 @default.
• W2886498839 hasConcept C535046627 @default.
• W2886498839 hasConcept C71924100 @default.
• W2886498839 hasConcept C87813604 @default.
• W2886498839 hasConcept C96608239 @default.
• W2886498839 hasConcept C99454951 @default.
• W2886498839 hasConceptScore W2886498839C105795698 @default.
• W2886498839 hasConceptScore W2886498839C119857082 @default.
• W2886498839 hasConceptScore W2886498839C122507166 @default.
• W2886498839 hasConceptScore W2886498839C126322002 @default.
• W2886498839 hasConceptScore W2886498839C129848803 @default.
• W2886498839 hasConceptScore W2886498839C141071460 @default.
• W2886498839 hasConceptScore W2886498839C142724271 @default.
• W2886498839 hasConceptScore W2886498839C148482608 @default.
• W2886498839 hasConceptScore W2886498839C204787440 @default.
• W2886498839 hasConceptScore W2886498839C27081682 @default.
• W2886498839 hasConceptScore W2886498839C2776239304 @default.
• W2886498839 hasConceptScore W2886498839C2778385053 @default.
• W2886498839 hasConceptScore W2886498839C2780367336 @default.
• W2886498839 hasConceptScore W2886498839C2908647359 @default.
• W2886498839 hasConceptScore W2886498839C33923547 @default.
• W2886498839 hasConceptScore W2886498839C41008148 @default.
• W2886498839 hasConceptScore W2886498839C535046627 @default.
• W2886498839 hasConceptScore W2886498839C71924100 @default.
• W2886498839 hasConceptScore W2886498839C87813604 @default.
• W2886498839 hasConceptScore W2886498839C96608239 @default.
• W2886498839 hasConceptScore W2886498839C99454951 @default.
• W2886498839 hasLocation W28864988391 @default.
• W2886498839 hasLocation W28864988392 @default.
• W2886498839 hasOpenAccess W2886498839 @default.
• W2886498839 hasPrimaryLocation W28864988391 @default.
• W2886498839 hasRelatedWork W1983054009 @default.
• W2886498839 hasRelatedWork W1984889650 @default.
• W2886498839 hasRelatedWork W2023105019 @default.

• next