Further investigation of safety monitoring guidelines based on magnetic resonance imaging lesion activity in multiple sclerosis clinical trials.
We assess two modified guidelines for monitoring patient safety in multiple sclerosis (MS) trials. These guidelines flag patients with an increase in contrast enhancing lesion (CEL) count above a threshold over the CEL level 1-2 months earlier. We compare the new guidelines to the original guideline where the threshold is set according to the baseline by applying the guidelines to two previous studies. The odds ratios of a subsequent clinical relapse associated with meeting the CEL threshold based on the modified guidelines are similar to those based on the original guideline. There is a need for patient and cohort specific monitoring procedures.
University of British Columbia, Canada.
Jing
J
Dong
MS/MRI Research Group, University of British Columbia, Canada yinshan@msmri.medicine.ubc.ca.
Yinshan
Y
Zhao
University of British Columbia, Canada.
A John
AJ
Petkau
University of British Columbia, Canada.
David Kb
DK
Li
University of British Columbia, Canada.
Andrew
A
Riddehough
University of British Columbia, Canada.
Anthony
A
Traboulsee
D000328:Adult; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000592:standards*; D009103:Multiple Sclerosis / Q000175:diagnosis*; D061214:Patient Safety / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012008:Recurrence; D013997:Time Factors
Clinical trials methodology; contrast-enhancing lesions; magnetic resonance imaging; multiple sclerosis; patient safety