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Abstract:
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Candidate biomarkers discovered in the laboratory need to be rigorously validated before advancing to clinical application. However, it is often expensive and time-consuming to collect the high quality specimens needed for validation; moreover, such specimens are often limited in volume. The Early Detection Research Network has developed valuable specimen reference sets that can be used by multiple labs for biomarker validation. To efficiently utilize the limited specimens in these reference sets, we propose a novel two-stage validation strategy that partitions the samples in the reference set into two groups for sequential validation and rotates group membership to maximize the usage of available samples. We develop analytical formulas for performance parameters of this strategy, which can provide valuable guidance for future study design. Compared with the default strategy of validating each biomarker using all available samples in the reference set, our proposed strategy allows more candidate biomarkers to be evaluated and provides a better chance of finding truly useful biomarkers.
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