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FRIDAY, May 31, 2019 (HealthDay News) — The International Pediatric Multiple Sclerosis Study Group has updated standards for future clinical trials in pediatric multiple sclerosis (MS); the new recommendations were published in the May 28 issue of Neurology<\/i>.<\/p>\n
Emmanuelle Waubant, M.D., Ph.D., from the University of California San Francisco MS Center, and colleagues reviewed advances in the understanding of pediatric-onset MS and the advent of clinical trials in this population.<\/p>\n
The authors note that convincing evidence has emerged in the last few years that the biological processes involved in MS are mainly shared across the age span. Consequently, there is a biological rationale for using treatments proven efficacious for adults with MS in pediatric MS. There are ethical considerations for conducting clinical trials in this age group, including placebo use in a highly active disease. Regulatory recommendations for future trials in pediatric patients include harmonizing clinical trial design requirements for pediatric therapeutic trials, limiting performance of phase 3 clinical trials to one for a pharmacologic agent, early use of in vitro and animal studies to avoid postponing appropriate testing, and use of pediatric pharmacodynamic\/pharmacokinetic studies for all new agents to establish dosage. Future trials in adults should consider enrolling teenagers, and open-label studies should be considered as sufficient for drugs that have been well-studied in adults.<\/p>\n
“We are confident these consensus recommendations will help address the need for high-quality evidence to inform the optimal treatment of children and teens living with multiple sclerosis,” Waubant said in a statement.<\/p>\n
Several authors disclosed financial ties to the pharmaceutical industry.<\/p>\n