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.