Matches in SemOpenAlex for { <https://semopenalex.org/work/W2591144847> ?p ?o ?g. }
Showing items 1 to 69 of
69
with 100 items per page.
- W2591144847 endingPage "34" @default.
- W2591144847 startingPage "34" @default.
- W2591144847 abstract "34 Background: Phase II clinical trials aim to identify promising experimental regimens for further testing in phase III trials. Testing targeted therapies with predictive biomarkers mandates efficient trial designs. Current biomarker-based trial designs, including the enrichment, all-comers, and adaptive designs, randomize patients to receive treatment or not throughout the entire duration of the trial. Recognizing the need for randomization yet acknowledging the possibility of promising but nonconclusive results after a preplanned interim analysis (IA), we propose a two-stage phase II design that allows for the possibility of direct assignment (i.e., stop randomization and assign all patients to the experimental arm in stage II) based on IA results. Methods: Using simulations, we compared properties of the direct assignment option design to a 1:1 randomized phase II design and assessed the impact of the timing of IA (after 33%, 50%, or 67% of accrual) and number of IA (one versus two with option for direct assignment at the first and second) over a range of response rate ratios (between 1.0 and 3.0). Results: Between 12% and 30% of the trials (out of 6,000 simulated trials) adopt direct assignment in stage II, with direct adoption depending on the treatment effect size and specified type I error rate (TIER). The direct assignment option design has minimal loss in power (<1.8%) and minimal increase in T1ER (<2.1%) compared to a 1:1 randomized design. The maximum loss in power across possible timings of IA was <1.2%. For the direct assignment option design, there was a 20%-50% increase in the number of patients treated on the experimental (vs. control) arm for the 1 IA case, and 40%-100% increase for the 2 IA case. Conclusions: Testing predictive biomarkers in clinical trials requires new design strategies. In the spectrum of phase II designs from adaptive to balanced randomized all-comers or enrichment designs, the direct assignment design provides a middle ground with desirable statistical properties that may appeal to both clinicians and patients." @default.
- W2591144847 created "2017-03-03" @default.
- W2591144847 creator A5002528975 @default.
- W2591144847 creator A5023299002 @default.
- W2591144847 creator A5082883769 @default.
- W2591144847 date "2012-10-20" @default.
- W2591144847 modified "2023-09-23" @default.
- W2591144847 title "A phase II trial design with direct assignment option for initial marker validation." @default.
- W2591144847 doi "https://doi.org/10.1200/jco.2012.30.30_suppl.34" @default.
- W2591144847 hasPublicationYear "2012" @default.
- W2591144847 type Work @default.
- W2591144847 sameAs 2591144847 @default.
- W2591144847 citedByCount "1" @default.
- W2591144847 countsByYear W25911448472013 @default.
- W2591144847 crossrefType "journal-article" @default.
- W2591144847 hasAuthorship W2591144847A5002528975 @default.
- W2591144847 hasAuthorship W2591144847A5023299002 @default.
- W2591144847 hasAuthorship W2591144847A5082883769 @default.
- W2591144847 hasConcept C105795698 @default.
- W2591144847 hasConcept C126322002 @default.
- W2591144847 hasConcept C129848803 @default.
- W2591144847 hasConcept C148482608 @default.
- W2591144847 hasConcept C166957645 @default.
- W2591144847 hasConcept C168563851 @default.
- W2591144847 hasConcept C204243189 @default.
- W2591144847 hasConcept C2776957806 @default.
- W2591144847 hasConcept C2779318504 @default.
- W2591144847 hasConcept C33923547 @default.
- W2591144847 hasConcept C40696583 @default.
- W2591144847 hasConcept C535046627 @default.
- W2591144847 hasConcept C61943457 @default.
- W2591144847 hasConcept C71924100 @default.
- W2591144847 hasConcept C95457728 @default.
- W2591144847 hasConceptScore W2591144847C105795698 @default.
- W2591144847 hasConceptScore W2591144847C126322002 @default.
- W2591144847 hasConceptScore W2591144847C129848803 @default.
- W2591144847 hasConceptScore W2591144847C148482608 @default.
- W2591144847 hasConceptScore W2591144847C166957645 @default.
- W2591144847 hasConceptScore W2591144847C168563851 @default.
- W2591144847 hasConceptScore W2591144847C204243189 @default.
- W2591144847 hasConceptScore W2591144847C2776957806 @default.
- W2591144847 hasConceptScore W2591144847C2779318504 @default.
- W2591144847 hasConceptScore W2591144847C33923547 @default.
- W2591144847 hasConceptScore W2591144847C40696583 @default.
- W2591144847 hasConceptScore W2591144847C535046627 @default.
- W2591144847 hasConceptScore W2591144847C61943457 @default.
- W2591144847 hasConceptScore W2591144847C71924100 @default.
- W2591144847 hasConceptScore W2591144847C95457728 @default.
- W2591144847 hasIssue "30_suppl" @default.
- W2591144847 hasLocation W25911448471 @default.
- W2591144847 hasOpenAccess W2591144847 @default.
- W2591144847 hasPrimaryLocation W25911448471 @default.
- W2591144847 hasRelatedWork W2018627447 @default.
- W2591144847 hasRelatedWork W2040878127 @default.
- W2591144847 hasRelatedWork W2069870586 @default.
- W2591144847 hasRelatedWork W2094445552 @default.
- W2591144847 hasRelatedWork W2138201488 @default.
- W2591144847 hasRelatedWork W2139024834 @default.
- W2591144847 hasRelatedWork W2292909008 @default.
- W2591144847 hasRelatedWork W2406649301 @default.
- W2591144847 hasRelatedWork W2505794677 @default.
- W2591144847 hasRelatedWork W3024239282 @default.
- W2591144847 hasVolume "30" @default.
- W2591144847 isParatext "false" @default.
- W2591144847 isRetracted "false" @default.
- W2591144847 magId "2591144847" @default.
- W2591144847 workType "article" @default.