ArticleContemporary clinical trials communications2019
Effects of biomarker diagnostic accuracy on biomarker-guided phase 2 trials.
Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Large scale validation of an early-age eye-tracking biomarker of an autism spectrum disorder subtype.Scientific reports · 2022Article
- Rapid, multiplexed detection of biomolecules using electrically distinct hydrogel beads.Lab on a chip · 2020Article
- An overview of precision oncology basket and umbrella trials for clinicians.CA: a cancer journal for clinicians · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent advancements in genomics have attracted attention towards biomarker-guided trials. These trials aim to identify therapies that target diseases based on their genetic profile, and are especially common in cancer research. Careful incorporation of biomarkers in phase II studies is critical to the selection of candidates for further phase III investigation. This short communication focuses on problems of biomarker test accuracy in biomarker-guided trials. We assessed how diagnostic accuracy of biomarker tests affects type I error rate, statistical power, and sample size requirements of single-arm biomarker-guided trials. In particular, we report how false positive rates (FPRs) of biomarker tests reduce statistical power and type I error for Simon's two-stage design, and the degree of sample size correction required to achieve pre-specified power and type I error with varying FPRs. This was done using a case study based on a previous biomarker-guided single-arm trial that was designed with an assumed tumor response rate of 10% under the null hypothesis and 40% for the alternative hypothesis for the mutant group for 5% type I error and 90% power. With varying FPRs of biomarker tests, we considered two scenarios in which the response rate for the wild-type group was assumed to be lower than the response rate for the mutant group at 5% and 10%. We also developed a simple open-source online trial planner for future investigators to use for their biomarker-guided phase II trials (https://mtek.shinyapps.io/Biomarker_Trial_Planner/).
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Registered trials
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