Children with multiple sclerosis should not become therapeutic hostages.

ABSTRACT:

Background

Both the United States (US) Food and Drug Administration (FDA) and the European Union (EU) European Medicines Agency (EMA) order pediatric clinical trials as a condition for approval of new compounds. We evaluate clinical value and likelihood of sufficient recruitment for pediatric multiple sclerosis (pMS) studies and discuss US and EU pediatric legislation with pMS as a paradigm.

Methods

We analyzed pMS clinical trials requested by the FDA and the EMA and industry-sponsored pMS studies registered on www.clinicaltrials.gov and www.clinicaltrialsregister.eu.

Results

The FDA demands four and the EMA 15 pMS trials.

Conclusions

pMS is rare. Neither FDA nor EMA prioritize compounds for potential benefit in pMS. The EMA in particular orders multiple pMS st

SUBMITTER: Rose K 

PROVIDER: S-EPMC4994785 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature