Clinical trials in youth-onset type 2 diabetes: needs, barriers, and options

Current Diabetes Reports
Philip ZeitlerMitchell Geffner

Abstract

Youth-onset type 2 diabetes (T2D) is increasingly recognized as a disorder with substantial risk for long-term metabolic, cardiovascular, and renal morbidity and mortality, as well as individual and societal burden. Recent studies suggest that the disorder differs from adult-onset T2D in a variety of ways and that there is an urgent need for an expanded set of treatment options. However, demographic, economic, and social challenges limit the number of eligible candidates for clinical trials in youth-onset T2D, and a growing number trials mandated by regulatory agencies have created a circumstance in which too many trials are chasing too few eligible participants. A solution to this situation will require novel approaches to clinical trial design incorporating collaboration among clinical investigators, pharmaceutical sponsors, and regulatory agencies. If successful, this approach could also serve as a model for clinical trials in other rare and understudied pediatric disorders.

References

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Citations

Nov 4, 2016·Pediatric Diabetes·Ryan FarrellRose Gubitosi-Klug
Jul 13, 2017·Pediatric Research·Robin A HuffEarl W Seltzer
Jan 8, 2020·Journal of Pharmacokinetics and Pharmacodynamics·Clémence Rigaux, Bernard Sébastien
Jan 9, 2020·Annual Review of Public Health·Michael HendryxJuhua Luo
Jul 29, 2021·The New England Journal of Medicine·UNKNOWN TODAY Study GroupPhilip Zeitler
Sep 24, 2021·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Brooke M CurrieJoseph A Johnston

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