This is the second of a 3 lecture series on imaging biomarker development for prostate cancer.
In this lecture, I will show you that regulatory requirements for BM approval differ from the steps needed to build clinical value. The regulatory view is the minimum standard needed for transitioning from an imaging test to a clinically valued imaging test. The important concept is that the biomarker type, how it is intended to be used, the potential benefits and risks for patients, determine the level of evidence needed for regulatory qualification.
The link for lecture 1 introducing biomarkers can be found here: [ Ссылка ]
The link for lecture 2 on regulatory requirements can be found here: [ Ссылка ]
The link for lecture 3 on building clinical value can be found here: [ Ссылка ]
You can follow me on Twitter on the handle: @ProfPadhani
