Evaluating biomarkers for treatment selection from reproducibility studies.

ABSTRACT: We consider evaluating new or more accurately measured predictive biomarkers for treatment selection based on a previous clinical trial involving standard biomarkers. Instead of rerunning the clinical trial with the new biomarkers, we propose a more efficient approach which requires only either conducting a reproducibility study in which the new biomarkers and standard biomarkers are both measured on a set of patient samples, or adopting replicated measures of the error-contaminated standard biomarkers in the original study. This approach is easier to conduct and much less expensive than studies that require new samples from patients randomized to the intervention. In addition, it makes it possible to perform the estimation of the clinical performance quickly, since there will be no requir

SUBMITTER: Song X 

PROVIDER: S-EPMC8974242 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature