Pediatric Multiple Sclerosis

Pediatric clinical trials were not required for new therapeutics. As a result, children were often prescribed medications off-label based on data from adult studies, or were unable to receive potentially beneficial therapies because of a lack of official approval for use in the pediatric population. As this was deemed unethical and detrimental in some cases, legislation was recently approved that now mandates pediatric studies for all new therapeutics. With the prospect of pediatric clinical trials on the horizon, Verhey et al. performed a study aimed to estimate the sample sizes required for pediatric studies using both clinical and radiologic metrics . Prospective data from a national study of children and adolescents followed from their incident demyelinating attack were used, and sample size estimates were generated using outcomes of time to next relapse and annualized relapse rate (ARR) for placebo-controlled trials of 12 and 24 months’ duration. With the prospect of pediatric clinical trials on the horizon,Verhey et al. performed a study aimed to estimate the sample sizes required for pediatric studies using both clinical and radiologic metrics.Prospective data from a national study of children and adolescents followed from their incident demyelinating attack were used, and sample size estimates were generated using outcomes of time to next relapse and annualized relapse rate (ARR) for placebo-controlled trials of 12 and 24 months’ duration. Sona Narula, Clinical Trials in Pediatric Multiple Sclerosis: Pending Landscape and Challenges

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Last date updated on April, 2024