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.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Image CAPTCHA

Enter the characters shown in the image.

User menu

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 Publication2015
AuthorsDong, J, Zhao, Y, Petkau, AJ, Li, DKB, Riddehough, A, Traboulsee, A
JournalMultiple Sclerosis Journal
Volume21
Pagination101-104
KeywordsClinical trials methodology, contrast-enhancing lesions, magnetic resonance imaging, multiple sclerosis, patient safety
Abstract

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.

URLhttp://msj.sagepub.com/content/early/2014/05/20/1352458514533846
DOI10.1177/1352458514533846