Barriers to participation in industry-sponsored clinical trials in pediatric type 2 diabetes.
BACKGROUND
The rapid emergence of type 2 diabetes (T2D) in the pediatric population has left pediatric endocrinologists with limited artillery in terms of management. While multiple medications are available for adults, Food and Drug Administration (FDA)-approved medications in children are limited to only metformin and insulin. Additional treatment options require randomized controlled trials, yet heretofore several barriers at the participant and institutional level have impeded these studies from proceeding in children and adolescents. Identification of the most challenging obstacles that pediatric endocrinologists experience in participating in industry-sponsored T2D trials may facilitate development of feasible platforms for future studies.


METHODS
We conducted an anonymous online survey consisting of 31 questions that assessed potential barriers to industry-sponsored clinical trials in pediatric patients with T2D. The survey was sent to members of the Pediatric Endocrine Society (PES), and members conducted the survey between October and November of 2014. As part of the survey, respondents rated the significance of several possible barriers to participation in industry-sponsored T2D studies.


RESULTS
We received a total of 207 responses from members of PES. Baseline demographics showed that 50% of represented institutions care for 50 or fewer T2D patients age 18 years and younger; 70% of institutions diagnose 20 or fewer new T2D cases per year; and 3 racial groups predominated: African American, Hispanic, and Caucasian. A total of 70% of responders have a research infrastructure to participate in clinical trials, but only half have dedicated research nurses. Protocol restrictions on participant recruitment due to current glycemic control or medication use as well as frequent visit schedules were reported to be major obstacles. In addition, the financial support provided to centers to carry out the studies is insufficient.


CONCLUSIONS
Efforts must be made to ease the burden of research participation on both pediatric T2D patients as well as pediatric endocrinologists.
Department of Pediatrics, University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio.
Ryan
R
Farrell
Department of Pediatrics, University at Buffalo Jacobs School of Medicine & Biomedical Sciences, Women and Children's Hospital of Buffalo, Buffalo, New York.
Kathleen
K
Bethin
Department of Pediatrics, University of Colorado School of Medicine, Barbara Davis Center for Childhood Diabetes, Denver, Colorado.
Georgeanna
G
Klingensmith
Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut.
William V
WV
Tamborlane
Department of Pediatrics, University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio.
Rose
R
Gubitosi-Klug
D000293:Adolescent; D001291:Attitude of Health Personnel; D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000191:economics; D017277:Drug Approval; D004345:Drug Industry / Q000191:economics; D015507:Drugs, Investigational / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D004704:Endocrinology; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D020407:Internet; D020380:Needs Assessment; D018579:Patient Selection; D010372:Pediatrics; D016032:Randomized Controlled Trials as Topic / Q000191:economics; D012108:Research Personnel; D012109:Research Support as Topic; D012958:Societies, Scientific; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration; D000078329:Workforce
D015507:Drugs, Investigational; D007004:Hypoglycemic Agents
clinical trials; pediatrics; type 2 diabetes