Risks in biomarker analysis resulting in unfit data use in clinical drug development

“Often, there is the temptation to use exploratory data to support claims of safety or efficacy without the rigor and scrutiny of reliable data generation.” Exciting advancements in research and development have led to biomarker applications that enter the clinical arena. Predictive biomarkers can help to determine the appropriate drug candidate, dosage and time frequency, and the drug effect can be confirmed later by physiological responses. Early decisions can also be made for patient treatment with the help of appropriate prognostic biomarker data. However, hidden analytical risks may compromise the result and, ultimately, the clinical decision. These risks must be...