Remove Assay Development Remove Disease Remove Trials Remove Workshop
article thumbnail

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [

FDA 40
article thumbnail

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. after ischemic heart disease and stroke. This enables patient selection, stratification and other adjustment in clinical trial design planning.