Biomarker study design

In every study, the design is key. It is particularly true in exploratory biomarker studies, where statistical power cannot be controlled and where sample logisitics can have an important impact on input data quality and availability.

 

Quartz Bio data scientists have analysed numerous biomarker studies and have experienced many cases where design flaws impacted negatively the analysis.

This expertise is routinely used a posteriori in the Quality Control process, but could also better be used before generating the data, i.e. at the design stage. Thus, reviewing the exploratory part of the Clinical Study Protocol and affiliated documents such as Analytical Plans or Manual of Operations could permit optimising the biomarker study design.