Bruce Cree: Long-Term Data Collection in MS Studies


At MS Paris 2017, MD Magazine sat with experts and key opinion leaders in the treatment of multiple sclerosis (MS) to discuss the important and innovative topics from the conference.

Bruce Cree, MD, PhD, is an associate professor of clinical neurology at the University of California at San Francisco Medical School and a key leader of thought in the MS space. Cree discussed the importance of long-term data collection in MS studies, noting that since MS is a disease that is observed in decades, so should its data. He spoke about the way clinical trials have been conducted in MS over the past few decades.

Cree was part of the EPIC study, involving more than 500 patients with MS that has been ongoing since 2004, and has maintained a high retention rate - something Cree stressed is of utmost importance in MS data collection.

Bruce Cree, MD, PhD:

Well, I think the eye is drawn to the features that are most immediately apparent. You put it on an MRI scan and you have got a big white spot in the white matter on the MRI, and your eye is drawn to it. You can't help but notice it, and so we're attracted to the things that are most immediately apparent - relapses, Gd+ enhancing lesions, new lesions - on the MRI. These are things that we see right away and we're drawn to them, but you have to kind of take a step back and ask the question, "Well, are those things the true mediators of long-term worsening?"

You have to do the studies correctly. One of the features of our study, that is, I think, an important component, is we have very little attrition - 91% of our patients were available for assessment after 10 years. Other studies that have been 10-year studies have had 40% or 50% of patients. Patients get lost to follow-up. We demonstrated that it is feasible to get high ascertainment traits.

In 1 of the studies that I described earlier, which was an examination of mortality from the interferon beta-1b pivotal trial - that study had 98% ascertained after 21 years. In a subsequent presentation after mine this morning, there was data from the British Columbia and Red France group that showed exactly the same results. That treatment with interferon beta-1b is associated with a significant reduction in MS-related mortality.

So now we have these 2 independent data sets basically proving the same point. The point being is with really patient ascertainment from either large-scale observational studies or carefully meticulously, deeply, phenotype cohort studies like ours, you can learn a wealth of information that you simply can't obtain from a short-lived, 2-year or 1-year duration randomized control trials.

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