Further investigation of safety monitoring guidelines based on magnetic resonance imaging lesion activity in multiple sclerosis clinical trials

Subscribe to email list

Please select the email list(s) to which you wish to subscribe.

You are here

Further investigation of safety monitoring guidelines based on magnetic resonance imaging lesion activity in multiple sclerosis clinical trials

TitleFurther investigation of safety monitoring guidelines based on magnetic resonance imaging lesion activity in multiple sclerosis clinical trials
Publication TypeJournal Article
Year of Publication2014
AuthorsDong, J, Zhao, Y, A. Petkau, J, Li, DKB, Riddehough, A, Traboulsee, A
JournalMultiple Sclerosis Journal
Pagination1352458514533846
ISSN1352-4585, 1477-0970
KeywordsClinical trials methodology, contrast-enhancing lesions, magnetic resonance imaging, multiple sclerosis, patient safety
AbstractWe 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.
URLhttp://msj.sagepub.com/content/early/2014/05/20/1352458514533846
DOI10.1177/1352458514533846