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Barriers to participation in industry-sponsored clinical trials in pediatric type 2 diabetes

Ryan Farrell1, Kathleen Bethin2, Georgeanna Klingensmith3

  • 1Department of Pediatrics, University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio.

Pediatric Diabetes
|November 4, 2016
PubMed

Insights

Pediatric endocrinologists face significant barriers in conducting type 2 diabetes (T2D) clinical trials, including restrictive protocols and insufficient funding. Addressing these challenges is crucial for advancing pediatric T2D research and improving patient care.

Area of Science:

  • Pediatric Endocrinology
  • Clinical Trial Management
  • Type 2 Diabetes Research

Background:

  • Rising rates of pediatric type 2 diabetes (T2D) necessitate expanded treatment options beyond metformin and insulin.
  • Current FDA-approved medications for pediatric T2D are limited, highlighting the need for further clinical trials.
  • Participant and institutional barriers impede the progress of essential T2D clinical trials in children and adolescents.

Purpose of the Study:

  • To identify and assess the primary obstacles encountered by pediatric endocrinologists in industry-sponsored T2D clinical trials.
  • To inform the development of more effective and feasible research platforms for pediatric T2D studies.

Main Methods:

  • An anonymous online survey with 31 questions was distributed to members of the Pediatric Endocrine Society (PES).
  • The survey, conducted in October-November 2014, assessed perceived barriers to industry-sponsored T2D trials in pediatric populations.
  • Respondents rated the significance of various potential impediments to trial participation.

Main Results:

  • 207 PES members responded, with many institutions managing a limited number of pediatric T2D patients annually.
  • While 70% of respondents have research infrastructure, only half possess dedicated research nurses.
  • Major obstacles include protocol restrictions on recruitment (glycemic control, medication use) and frequent visit schedules; insufficient financial support was also noted.

Conclusions:

  • Significant barriers hinder pediatric endocrinologists' participation in T2D clinical trials.
  • Addressing issues like protocol restrictions and funding is essential to facilitate research.
  • Streamlining participation for both patients and clinicians is vital for advancing pediatric T2D management.
Abstract

Keywords:
clinical trialspediatricstype 2 diabetes

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