Biomedical Engineering Reference
In-Depth Information
FIGURE 9.1
Translational medicine: accelerating the progression of scientific advances
from the bench to the bedside.
generated by clinical scientists characterizing the pathology and pathophysiology of
diseases.
Early clinical trials primarily assess pharmacokinetics (PK) and safety in the
human population, but they now also evaluate efficacy through the inclusion of
pharmacodynamic (PD) biomarkers. The most accepted definition of a biomarker is a
“biological substance or features that can be used to indicate normal biological
process, disease process, or responses to therapy” [5]. PD biomarkers are included in
clinical trials under the supposition that they may substitute for, or augment, defined
clinical end points. By utilizing PD biomarkers that represent the disease pathology,
indications of efficacy can be obtained early on in the clinical development process in
smaller clinical trials and thus potentially “buy down the risk” of costly, large, late-
stage trials that focus on clinical outcomes [6]. In addition, PD biomarkers can
potentially help bridge the gap between drug discovery and clinical development that
is especially important for novel drug targets that have not yet been tested in the
human population [7].
For an effective use of PD biomarker data, the following questions will be
addressed during analysis: Is there a correlation between the PK data and the PD
biomarker? Is there a relationship between the drug activity and the PD biomarker? Is
there a correlation between the PD biomarker and the clinical outcome?
The translational medicine approach provides details to these questions not in a
unidirectional manner, but rather provides a dynamic cyclical flow of information. In
the translational medicine cycle, the PD biomarker data are used by scientists, moving
through each stage from basic research to drug and compound development. By
completing the translational medicine cycle, data from the clinical trials can provide
FIGURE 9.2
Drug development lifecycle.
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