Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.

CONCLUSIONS: By ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. PMID: 31758549 [PubMed - as supplied by publisher]

https://www.ncbi.nlm.nih.gov/pubmed/31758549?dopt=Abstract

Source: Headache - November 21, 2019 Category: Neurology Authors: Hornik CP, Gelfand AA, Szperka CL, Pezzuto T, Utevsky A, Kessel S, McCune S, Alexander JJ, Benjamin DK, Cohen-Wolkowiez M Tags: Headache Source Type: research