Sample size methods for evaluation of predictive biomarkers.

ABSTRACT: Treatment selection biomarkers are those that can be useful in guiding choice of therapy. Just as new therapies require evaluation in appropriately designed clinical trials to determine their benefit, therapy selection biomarkers require evaluation in appropriately designed studies. These studies may be prospective clinical trials or retrospective studies based on specimens stored from a completed clinical trial. Ideally, patient treatment assignments should be randomized, and consideration should be given to an appropriate sample size-either for prospective planning of a new study or access to a sufficient number of stored specimens. Here, we develop a novel sample size method for estimation of a confidence interval of specified average width, for an intuitively appealing previously propo

SUBMITTER: Dobbin KK 

PROVIDER: S-EPMC9233020 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature