Matches in SemOpenAlex for { <https://semopenalex.org/work/W4378800512> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W4378800512 endingPage "OF8" @default.
- W4378800512 startingPage "OF1" @default.
- W4378800512 abstract "Early phase cancer prevention trials are designed to demonstrate safety, tolerability, feasibility, and signals of efficacy of preventive agents. Yet it is often observed that many trials fail to detect intervention effects. We conducted a systematic review and pooled analyses of recently completed early phase chemoprevention trials to gain in depth insight on the failure of detecting efficacy signals by comparing hypothesized effect sizes to the corresponding observed effect sizes.Single- or multi-arm efficacy chemoprevention trials conducted under the phase 0/I/II Cancer Prevention Clinical Trials Program of the Division of Cancer Prevention, NCI between 2003 and 2019 were evaluated. A total of 59 chemoprevention trials were reviewed. Twenty-four studies were efficacy or biomarker trials with complete information on hypothesized and observed effect sizes and included in this analysis. The majority of the trials (n = 18) were multi-arm randomized studies of which 15 trials were blinded. The pooled estimate of the observed to hypothesized effect size ratio was 0.57 (95% confidence interval: 0.42-0.73, P < 0.001) based on a random-effects model. There were no significant differences detected in the ratio of observed to hypothesized effect sizes when conducting various subgroup analyses.The results demonstrate that the majority of early phase cancer chemoprevention trials have substantially smaller observed effect sizes than hypothesized effect sizes. Sample size calculations for early phase chemoprevention trials need to balance the potential detectable effect sizes with realistic and cost-effective accrual of study populations, thereby, detecting only intervention effects large enough to justify subsequent large-scale confirmatory trials.The results of this systematic review and pooled analyses demonstrate that for early chemoprevention trials, there are substantial differences between hypothesized and observed effect sizes, regardless of study characteristics. The conduct of early phase chemoprevention trial requires careful planning of study design, primary endpoint, and sample size determination." @default.
- W4378800512 created "2023-06-01" @default.
- W4378800512 creator A5001986524 @default.
- W4378800512 creator A5020366697 @default.
- W4378800512 creator A5027317558 @default.
- W4378800512 creator A5032664810 @default.
- W4378800512 creator A5049172335 @default.
- W4378800512 creator A5049889117 @default.
- W4378800512 creator A5091511322 @default.
- W4378800512 date "2023-06-27" @default.
- W4378800512 modified "2023-09-29" @default.
- W4378800512 title "A Systematic Review and Pooled Analysis of Hypothesized versus Observed Effect Sizes in Early Phase Cancer Prevention Clinical Trials" @default.
- W4378800512 cites W1744285115 @default.
- W4378800512 cites W2030223911 @default.
- W4378800512 cites W2058763863 @default.
- W4378800512 cites W2083637030 @default.
- W4378800512 cites W2104586902 @default.
- W4378800512 cites W2107328434 @default.
- W4378800512 cites W2109172374 @default.
- W4378800512 cites W2126930838 @default.
- W4378800512 cites W2146740605 @default.
- W4378800512 cites W2470883339 @default.
- W4378800512 cites W2750245291 @default.
- W4378800512 cites W3118615836 @default.
- W4378800512 doi "https://doi.org/10.1158/1940-6207.capr-23-0060" @default.
- W4378800512 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37258421" @default.
- W4378800512 hasPublicationYear "2023" @default.
- W4378800512 type Work @default.
- W4378800512 citedByCount "0" @default.
- W4378800512 crossrefType "journal-article" @default.
- W4378800512 hasAuthorship W4378800512A5001986524 @default.
- W4378800512 hasAuthorship W4378800512A5020366697 @default.
- W4378800512 hasAuthorship W4378800512A5027317558 @default.
- W4378800512 hasAuthorship W4378800512A5032664810 @default.
- W4378800512 hasAuthorship W4378800512A5049172335 @default.
- W4378800512 hasAuthorship W4378800512A5049889117 @default.
- W4378800512 hasAuthorship W4378800512A5091511322 @default.
- W4378800512 hasConcept C105795698 @default.
- W4378800512 hasConcept C121608353 @default.
- W4378800512 hasConcept C126322002 @default.
- W4378800512 hasConcept C129848803 @default.
- W4378800512 hasConcept C143998085 @default.
- W4378800512 hasConcept C168563851 @default.
- W4378800512 hasConcept C197934379 @default.
- W4378800512 hasConcept C2778375690 @default.
- W4378800512 hasConcept C2780234812 @default.
- W4378800512 hasConcept C33923547 @default.
- W4378800512 hasConcept C44249647 @default.
- W4378800512 hasConcept C535046627 @default.
- W4378800512 hasConcept C71924100 @default.
- W4378800512 hasConcept C95190672 @default.
- W4378800512 hasConceptScore W4378800512C105795698 @default.
- W4378800512 hasConceptScore W4378800512C121608353 @default.
- W4378800512 hasConceptScore W4378800512C126322002 @default.
- W4378800512 hasConceptScore W4378800512C129848803 @default.
- W4378800512 hasConceptScore W4378800512C143998085 @default.
- W4378800512 hasConceptScore W4378800512C168563851 @default.
- W4378800512 hasConceptScore W4378800512C197934379 @default.
- W4378800512 hasConceptScore W4378800512C2778375690 @default.
- W4378800512 hasConceptScore W4378800512C2780234812 @default.
- W4378800512 hasConceptScore W4378800512C33923547 @default.
- W4378800512 hasConceptScore W4378800512C44249647 @default.
- W4378800512 hasConceptScore W4378800512C535046627 @default.
- W4378800512 hasConceptScore W4378800512C71924100 @default.
- W4378800512 hasConceptScore W4378800512C95190672 @default.
- W4378800512 hasLocation W43788005121 @default.
- W4378800512 hasLocation W43788005122 @default.
- W4378800512 hasOpenAccess W4378800512 @default.
- W4378800512 hasPrimaryLocation W43788005121 @default.
- W4378800512 hasRelatedWork W1569663381 @default.
- W4378800512 hasRelatedWork W1900595920 @default.
- W4378800512 hasRelatedWork W1997239045 @default.
- W4378800512 hasRelatedWork W2056160070 @default.
- W4378800512 hasRelatedWork W2087016115 @default.
- W4378800512 hasRelatedWork W2107697672 @default.
- W4378800512 hasRelatedWork W2531052508 @default.
- W4378800512 hasRelatedWork W2889691785 @default.
- W4378800512 hasRelatedWork W3028296069 @default.
- W4378800512 hasRelatedWork W4221132908 @default.
- W4378800512 isParatext "false" @default.
- W4378800512 isRetracted "false" @default.
- W4378800512 workType "article" @default.