Wednesday , June 29 2022

Global agreement has been reached on standards for clinical trials in children with multiple sclerosis


The Pediatric International MS Study Group (IPMSSG) has released updated standards for clinical trials involving children and young people with multiple sclerosis (MS). The new recommendations were published in the online edition of May 1, 2019 Neurology, American Academy of Neurology Academy medical journal.

The recommendations have been updated including: t

  • Pharmacokinetic / pharmacodynamic studies (how therapy is absorbed and how it affects the patient) should be completed for each new agent to identify the appropriate dose in children.
  • If it is proved that an adult modulation agent is effective in adult adults, it is inappropriate to prove that agent in pediatric MS using placebo control (inactive).
  • Phase 3 trials in adults should consider registering teenagers.
  • Open-label extension studies should be carried out.
  • In some cases, when therapies have been studied well in adults, an open label study should be considered sufficient for approval in pediatric MS.

"Fortunately, the number of pediatric MS cases is low compared to adult cases – but these are children, facing chronic illnesses and we need to do everything we can to & # 39 w help, "said lead author Emmanuelle Waubant, MD, Professor of Neurology at the University of California, San Francisco. "We are confident that these consensus recommendations will help to get to grips with the need for high quality evidence to inform the best possible treatment for children and teenagers. 39 living with multiple sclerosis. "

Clinical trials in children can be complex; Some issues include the low numbers of children with MS in any one study site, the need to get parental approval as well as the child agreeing to participate, and the fact that treatments can have a skill- t unexpected effects in immature individuals. The IPMSSG is a group of 165 care providers representing 44 countries, dedicated to optimizing global care, education and research in pediatric MS. In 2012, an international meeting was held to develop a consensus on how to conduct clinical trials in children with MS. In 2018, the need to update recommendations was acknowledged, and a meeting was convened in New York City in January, sponsored by the National MS Society (USA) and MS Society Canada.

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More information:
Emmanuelle Waubant et al, Clinical trials of disease modification agents in pediatric MS, t Neurology (2019). DOI: 10.1212 / WNL.0000000000007572

Provided by
National Multiple Sclerosis Association

Global agreement to reach standards for clinical trials in children with multiple sclerosis (2019, May 21) t
retrieved 21 May 2019

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