Applying Multiple Sclerosis Clinical Trial Outcomes to Practice


In this video segment, the expert panelists explain how the outcomes of multiple sclerosis (MS) clinical trials reflect or differ from the methods physicians actually use to diagnose and treat patients with the autoimmune disease.

“In a clinical trial, we do (neurologic examination) in a very standardized, quantitative fashion as much as we can — and as objectively as we can — by having what we call ‘blinded evaluators’ doing the testing or supervising the process so that they’re not aware whether the patient in the trial is receiving an active treatment or a placebo treatment,” Andrew D. Goodman, MD, FAAN, describes. “But in clinical practice, it’s quite difficult to do this kind of standardized, quantitative testing on every patient at every visit.”

According to Stephen Krieger, MD, pivotal MS clinical trials have instructed those in the clinical practice realm to pay attention to subtle changes on neurological exam results, as well as understand that “if a patient on a drug has a relapse, it’s too many” because the rate in the modern era is one relapse every 3-6 years.

Kreiger also says the trials have better informed clinicians’ treatment decisions, as he believes high-dose, high-frequency interferon therapies are more effective in preventing MS relapses than low-dose, once-weekly ones just based on the outcomes of head-to-head drug efficacy comparison trials.

In addition to efficacy results, Patricia K. Coyle, MD, considers a treatment’s side effects and tolerability in trials, as well as patient and disease factors.

“If you have a bad prognostic profile and you have very active disease, then efficacy may be very important,” Coyle explains. “If that’s not the case, then maybe that’s not the most significant feature.”

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