Other Challenges of Clinical Biomarker Validation

There are many additional barriers and concerns for clinical validation of biomarkers:

• Choice of matrix (readily accessible, effect on biomarker concentrations)

• Variability (interindividual and intraindividual)

• Preparing calibration standards

• Implementations of quality control to assure reproducibility

• Limited availability of clinical specimens

• Heterogeneity of biomarkers (isoforms, bound states)

• IP protection (lack of collaboration)

• Lack of clear regulatory guidance

As discussed, the discovery and validation processes involve multicenter studies with large patient cohorts and technical equipment, steered by a vast number of staff members. The enormous costs for these studies can in most cases be covered only by consortia, consisting potentially of academic centers and pharmaceutical companies. The establishment of such consortia often has to overcome legal hurdles and IP issues, which may be a time- consuming process. As mentioned above, establishment of a biomarker may involve the recruitment of hundreds of patients per treatment arm. Both recruitment time and success rate are unpredictable at the beginning of the study phase.

It is during the initial phase that the team needs to determine what really constitutes a good biomarker. Key questions in this decision include: What is the threshold for decision making that needs to be established to call a bio-marker "useful"? How do we achieve a "robust" biomarker: a marker that is not easily influenced by such factors as location and personnel? How economical does the biomarker test need to be for it to be used? Which biomarker matrix should be selected, since this may affect future validation possibilities? Accessible matrices such as urine or blood with limited or known concentration variability are ideal.

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