Randomized test-treatment studies with an outlook on adaptive designs.

ABSTRACT:

Background

Diagnostic accuracy studies aim to examine the diagnostic accuracy of a new experimental test, but do not address the actual merit of the resulting diagnostic information to a patient in clinical practice. In order to assess the impact of diagnostic information on subsequent treatment strategies regarding patient-relevant outcomes, randomized test-treatment studies were introduced. Various designs for randomized test-treatment studies, including an evaluation of biomarkers as part of randomized biomarker-guided treatment studies, are suggested in the literature, but the nomenclature is not consistent.

Methods

The aim was to provide a clear description of the different study designs within a pre-specified framework, considering their underlying assumptions, advanta

SUBMITTER: Hot A 

PROVIDER: S-EPMC8167391 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature