Table 1 Proposed criteria for neurophysiologic biomarkers

From: Selection criteria for neurophysiologic biomarkers to accelerate the pace of CNS therapeutic development

Psychometric properties of translational biomarkers

 • Established substantial test-retest reliability (intraclass correlations > 0.8)

 • Suitable for use as a repeated measure (i.e., no practice, maturation, instrumentation, testing or statistical regression effects)

Functional characteristics

 • Early sensitivity to single- or limited “doses” of pharmacologic agents, cognitive training or other CNS interventions

 • Consistent relationships to important domains of clinical, cognitive and/or psychosocial functioning in humans

Scalable for use in real-world multi-site global clinical trial settings

 • Equipment should be low cost with identical interchangeable calibrated systems and components

 • Measures are robust to variations in testers and testing environments

 • Tests can be administered by non-specialists with appropriate training, certification, and centralized quality assurance and oversight

 • Does not require special testing environments, suitable for valid use in varied multi-center settings

 • Objective automated analysis methods that are amenable to centralized data processing blinded to group and conditions

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