ELECTROPHYSIOLOGICAL MONITORING IN CLINICAL-TRIALS

Electrophysiological testing remains an important efficacy parameter i n clinical neuropathy trials. The quality of nerve conduction studies in reported trials varies greatly, and may be responsible for negative results. We report the utilization of an expert core lab for electrop hysiological testing. With the core lab, the variability of repeat tes ting is comparable to that of a single, excellent laboratory. Motor co nduction velocities demonstrated a coefficient of variation of 3% and sensory conduction velocities 4% across 60 study sites. The distal mot or evoked potential amplitudes varied by 13% at the ankle, and 10% at the wrist. The sensory potential amplitudes varied by 16% at the ankle , and 11% at the wrist in 60 sites. The overall monitoring rate in all submitted nerve conduction tracings was 36.6%. Our results show that an expert core lab can improve the electrophysiological quality of cli nical trial data with the potential to show small changes in nerve con duction velocities and in both motor and sensory potential amplitudes. (C) 1998 John Wiley & Sons, Inc. Muscle Nerve 21: 1368-1373, 1998.