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Development of a prospective real-world data clinical registry of children and adolescents with migraine

Headache: The Journal of Head and Face Pain Dec 04, 2019

Hornik CP, Gelfand AA, Szperka CL, et al. - In this multicenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17 years of age, diagnosed with migraine with or without aura, experts intended to create a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to encourage the collection of real-world data of adequate quality to promote regulatory submissions and give site-based infrastructure support for prospective clinical trials. Through making sure the regulatory compliant implementation of the registry, both a source of real-world data and a multisite stage for the conduct of prospective clinical trials that could be added to regulatory authorities to promote the incorporation of pediatric data in approved drug labeling was made. Moreover, a profoundly collaborative strategy with extensive stakeholder commitment at all stages of the registry development was a solution to operational success.
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