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The annual meeting of the Steering Committee of the International Pediatric MS Study Group (IPMSSG) was held in London, UK on the 25-26 September.
The meeting was co-hosted by MSIF, the US National MS Society and the MS Society of Canada.
The IPMSSG is a global network of neurologists, scientists, clinicians, and representatives of MS societies, whose unifying vision is to optimise worldwide healthcare, education and research in pediatric multiple sclerosis and other acquired inflammatory demyelinating disorders of the central nervous system.
MSIF and the MS societies of Canada, Italy and USA play a key role in coordinating and facilitating activities of the Study Group.
The main goal of the meeting was to develop a global consensus statement regarding the current knowledge about treatments in pediatric MS and recommendations for future studies and clinical trials in new and existing therapies. This statement would inform and guide clinicians, pharmaceutical companies and regulatory agencies, such as the Food and Drug Administration of the USA and the European Medicines Agency (EMA). The timeliness and importance of this meeting should be seen in the context of the urgent need for more research about efficacy and safety of treatments in pediatric MS and the new requirement by the EMA that all pharmaceutical companies submitting applications for drug approvals in adults must also present plans for how these drugs will be evaluated in children.
While the EMA prefers clinical trials that prove efficacy and demonstrate safety, exceptions can be made for drugs that raise specific concerns for use in children. With the emergence of several new drugs for MS in the pipeline, and the lack of a large enough pediatric MS population worldwide to participate in all the studies, careful planning is required to ensure safety and efficacy of studies while avoiding delay of approval of new drugs that could greatly benefit children and adolescents with MS.
The IPMSSG is uniquely situated to provide independent, expert opinion on best practice with regard to the use of new and existing treatments and to advise on the feasibility and advisability of efficacy and/or safety studies for the full range of new drugs in the MS pipeline.
The consensus statement is expected to be available before the end of 2010.
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