Measuring soluble biomarkers in clinical trials: do tiered approaches to the analysis and validation of assays provide an answer to the fit-for-purpose challenge?

“By adopting a tiered approach towards the validation and analysis of soluble biomarkers, true fit-for-purpose assays may be better achieved.”

The determination of soluble biomarkers has been an increasing feature of clinical trial investigations for some time. Through the quantitative determination of affected biochemical entities, investigators are attempting to harness the increasing knowledge of basic biological systems that underpin the consequences of intervention in disease mechanisms. It is almost universally acknowledged that by understanding the quantitative effects of pharmacology, better measures of efficacy, safety and outcomes will be achieved with consequent improvements in clinical trials and, ultimately, therapeutic effectiveness [1–3].

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