By Adam Aulbach, DVM, DACVP, MPI Research
Biomarkers are a useful tool in clinical trials, especially in identifying a drug’s impact on organs or tissues before any injury is clinically evident. It’s still early in their use in preclinical development; however, they are proving helpful in identifying major safety issues and showing promise for future use.
Presently, biomarkers are used with clinical and pathology endpoints to identify the effects of a preclinical drug candidate far earlier than do traditional tests alone. But sometimes those biomarkers can lead to conflicting data. The assays may be so sensitive that they show evidence of toxicity—often a submicroscopic effect—that doesn’t appear in conventional study endpoints. How to explain those results, and whether they are relevant, presents a challenge best addressed by consulting with a pathologist before designing a study. Understanding the timing of pathologic processes is critical to interpreting results.