Joining Forces: A Call for Greater Collaboration to Study New Medicines in Children and Adolescents With Type 2 Diabetes

被引:22
作者
Karres, Janina [1 ]
Pratt, Valerie [2 ]
Guettier, Jean-Marc [2 ]
Temeck, Jean [3 ]
Tamborlane, William V. [4 ]
Dunger, David [5 ]
Bejnariu, Cristina [1 ]
De Beaufort, Carine [6 ]
Tomasi, Paolo [1 ]
机构
[1] European Med Agcy, London, England
[2] US FDA, Div Metab & Endocrinol Prod, Silver Spring, MD USA
[3] US FDA, Off Pediat Therapeut, Silver Spring, MD USA
[4] Yale Univ, Sch Med, Ctr Clin Invest, New Haven, CT USA
[5] Univ Cambridge, Dept Paediat, Cambridge, England
[6] Univ Luxembourg, Ctr Syst Biomed, Esch Sur Alzette, Luxembourg
基金
英国医学研究理事会;
关键词
TODAY CLINICAL-TRIAL; YOUTH; PREVALENCE; COHORT; CARE;
D O I
10.2337/dc14-0494
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
A collaborative effort will facilitate the collection of adequate and well-controlled pediatric efficacy and safety clinical trial data to inform pediatric use of new drugs to treat T2D. An approach relying on a multiarm trial is one particularly attractive approach that leverages efficiencies gained from use of a shared control group, with efficiencies gained from a shared research infrastructure. Success in pediatric drug development has often involved collaboration. Indeed, reliance on consortia-based approaches to evaluate novel therapies was successful for other relatively uncommon pediatric diseases (e.g., juvenile idiopathic arthritis and schizophrenia) and should be met with similar success in T2D. © 2014 by the American Diabetes Association.
引用
收藏
页码:2665 / 2667
页数:3
相关论文
共 25 条
[1]  
[Anonymous], 2006, OFFICIAL J EUROPEAN
[2]  
[Anonymous], 2006, OFFICIAL J EUROPEAN
[3]  
[Anonymous], 2012, CONC PAP EXTR EFF SA
[4]  
[Anonymous], 2012, GUID CLIN INV MED PR
[5]   The Pediatric Diabetes Consortium: Improving Care of Children with Type 1 Diabetes Through Collaborative Research [J].
Beck, R. ;
Klingensmith, G. ;
Haymond, M. ;
Wood, J. ;
Buckingham, B. ;
Schatz, D. ;
Silverstein, J. ;
Lee, J. ;
Cengiz, E. ;
Tamborlane, W. .
DIABETES TECHNOLOGY & THERAPEUTICS, 2010, 12 (09) :685-688
[6]   Meeting the Demand for Pediatric Clinical Trials [J].
Connor, Edward M. ;
Smoyer, William E. ;
Davis, Jonathan M. ;
Zajicek, Anne ;
Ulrich, Linda ;
Purucker, Mary ;
Hirschfeld, Steven .
SCIENCE TRANSLATIONAL MEDICINE, 2014, 6 (227)
[7]   Characteristics of Adolescents and Youth with Recent-Onset Type 2 Diabetes: The TODAY Cohort at Baseline [J].
Copeland, Kenneth C. ;
Zeitler, Philip ;
Geffner, Mitchell ;
Guandalini, Cindy ;
Higgins, Janine ;
Hirst, Kathryn ;
Kaufman, Francine R. ;
Linder, Barbara ;
Marcovina, Santica ;
McGuigan, Paul ;
Pyle, Laura ;
Tamborlane, William ;
Willi, Steven .
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 2011, 96 (01) :159-167
[8]   Prevalence of Type 1 and Type 2 Diabetes Among Children and Adolescents From 2001 to 2009 [J].
Dabelea, Dana ;
Mayer-Davis, Elizabeth J. ;
Saydah, Sharon ;
Imperatore, Giuseppina ;
Linder, Barbara ;
Divers, Jasmin ;
Bell, Ronny ;
Badaru, Angela ;
Talton, Jennifer W. ;
Crume, Tessa ;
Liese, Angela D. ;
Merchant, Anwar T. ;
Lawrence, Jean M. ;
Reynolds, Kristi ;
Dolan, Lawrence ;
Liu, Lenna L. ;
Hamman, Richard F. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2014, 311 (17) :1778-1786
[9]   Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs [J].
Dunne, Julia ;
Rodriguez, William J. ;
Murphy, Dianne ;
Beasley, B. Nhi ;
Burckart, Gilbert J. ;
Filie, Jane D. ;
Lewis, Linda L. ;
Sachs, Hari C. ;
Sheridan, Philip H. ;
Starke, Peter ;
Yao, Lynne P. .
PEDIATRICS, 2011, 128 (05) :E1242-E1249
[10]  
European Medicines Agency , EUR NETW PAED RES EU