Key result
Expert core labs yield low variation of ~4% or less for motor and sensory conduction velocities.
Why the study?
The quality of nerve conduction studies in clinical neuropathy trials varies greatly and may contribute to negative trial results.
Does the utilization of an expert core lab improve the electrophysiological quality and reduce variability of clinical trial data in neuropathy trials?
Population
Clinical neuropathy trials across 60 study sites
Comparison
Use of expert core lab for electrophysiological testing vs standard testing
Design
Observational report on electrophysiological monitoring quality
Authors
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Core labs may standardize electrophysiology across multicenter neuropathy trials; leaves open impact on endpoint sensitivity.
Does the utilization of an expert core lab improve the electrophysiological quality and reduce variability of clinical trial data in neuropathy trials?
The use of an expert core lab in multicenter neuropathy trials can achieve low variability in electrophysiological testing, comparable to a single excellent laboratory.
Bril et al. (1998) studied Neuropathy. Expert core lab for electrophysiological testing was evaluated on Coefficient of variation for nerve conduction velocities and potential amplitudes. Utilization of an expert core lab for electrophysiological testing across 60 sites yielded low coefficients of variation for motor (3%) and sensory (4%) conduction velocities.
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