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Design of biomarker identification studies using
sequential samples from patients treated with
systemic therapies
In this manuscript, a multidisciplinary panel proposes a
methodological framework—the DESIGN
guidelines
—to standardize the clinical design of biomarker identification studies and to develop future
research in this pivotal field
:
a. Baseline samples
are obtained from all patients
treated with a particular drug
b. Sequential samples
are obtained whenever a
clinically relevant event (i.e., response, progression
or marked toxicity) is observed
03/28/2017