Alternate approaches for pediatric type 1 diabetes drug development and potential regulatory Approval: A perspective

J. Rick Turner, Kelly L. Close, G. Alexander Fleming, Diane Kwherrett, Linda DiMeglio

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

The incidence and prevalence of pediatric type 1 diabetes are increasing globally, including in the U.S. While the increasing number of cases of pediatric diabetes makes expeditious availability of newmedical products and therapies for diabetes care essential, there have beenmany barriers encountered in bringing some drugs and devices to pediatric patients who may benefit. Newer insulins have been studied and approved for use in children. However, hurdles exist in the inclusion of children in studies of therapies aimed at preventing b-cell loss in those with newonset diabetes and those at risk for type 1 diabetes. This Perspective focuses on potential solutions to the challenges experienced in bringing new drugs for pediatric type 1 diabetes to marketing approval. Given their central importance as the users of medical products, patient perspectives are included along with scientific and regulatory considerations.

Original languageEnglish (US)
Pages (from-to)1986-1991
Number of pages6
JournalDiabetes Care
Volume38
Issue number10
DOIs
StatePublished - Oct 1 2015

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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