RESEARCH TRIANGLE PARK, NC – Nov. 14, 2013 – To mark World Diabetes Day, Quintiles today published its perspectives on diabetes drug development with a special report on development for pediatric indications.
Diabetes is a pressing public health concern, affecting 366 million people and accounting for 11 percent of total health care expenditures in 2011. By 2030, this will have risen to 552 million[i]. In the pediatric population, nearly 5000 children died from diabetes mellitus worldwide in 2007[ii].
“Although the disease burden is growing, clinical trials are attacking diabetes on many different fronts, allowing those who treat diabetes to give a more patient-tailored approach for treatment,” said Erica Caveney, M.D., senior director, global diabetes therapeutic strategy head, Cardiovascular and Metabolic Therapeutic Delivery Unit, at Quintiles. “Whether our sponsors grapple with the challenge of designing trials in a renally-impaired diabetic population or are creating an insulin algorithm for a type one diabetes population, they turn to Quintiles for our extensive experience in clinical research.”
“Diabetes Drug Development: A Perspective on Pediatric Indication Planning,” co-authored by Quintiles’ Robin Huff, Ph.D., global pediatric regulatory strategy lead and Cynthia R. Jackson, DO, FAAP, global head, Pediatric Center of Excellence, Quintiles, discusses the significant burden of diabetes in children and adolescents, including the limited treatment options for pediatric patients with type 2 diabetes.
The report addresses specific clinical, design, and operational considerations for pediatric diabetes clinical trials. These factors include rational study design based on an understanding of developmental physiology, emotional development, and the particular clinical and pathologic manifestations of diabetes. The report concludes that the disease burden is high, with a large unmet need for new diabetes therapies in the pediatric population, and provides information to assist in the planning of pediatric studies aimed at making more treatment options available to children.
Quintiles’ perspectives on diabetes drug development are published on the company’s website: http://www.quintiles.com/perspectives-diabetes/
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