Precision Dosing in Clinical Studies Versus in Routine Clinical
Care
It must be emphasized that the levels of treatment oversight as well as
the characteristics of the patient populations in clinical studies are
significantly different from those in real-world patient care, which is
highly relevant for implementation of TDM. In routine patient care, the
timing of sample collection for trough levels is unlikely to be exact,
and there is increased likelihood of drug-drug and drug-food
interactions as well as other factors that could alter the relationships
between drug dose, trough levels, systemic exposure, and, subsequently,
biomarkers and treatment outcome. Prospective studies comparing TDM with
no TDM using clinical outcomes as the primary endpoint will therefore
need to be followed up by analysis of real-world patient data.