French pediatricians' views on industry-sponsored clinical trials: Toward stronger research on ethics?

S El Zoghbi1, A Jannot2, C Delacourt3

  • 1Équipe Éthique, Recherche, Translations (ETRES), composante du Centre de Recherche des Cordeliers, Paris Descartes University, UMRS 1138, 45, Rue des Saints-Pères, 75006 Paris, France; Necker-Enfants Malades Hospital, APHP Paris, 75015 Paris, France.

Insights

Pediatricians in France largely support pediatric clinical trials, but concerns about parental stress and child exploitation exist. Education in research ethics is recommended to ensure good clinical practice.

Area of Science:

  • Pediatric Clinical Trials
  • Medical Ethics
  • Healthcare Research

Background:

  • Increased prescription of unapproved drugs necessitates pediatric clinical trials.
  • Pediatricians play a critical role in facilitating pediatric research.
  • Limited data exists on French pediatricians' perspectives on clinical trials.

Purpose of the Study:

  • To assess French pediatricians' views on conducting clinical trials in children.
  • To identify factors influencing pediatricians' perceptions of pediatric clinical trials.
  • To evaluate the current landscape of pediatric research ethics education in France.

Main Methods:

  • An online survey was administered to 207 pediatricians in France.
  • The survey included 27 questions assessing views on clinical trials.
  • Statistical analysis (Fisher's exact test) explored correlations between pediatrician characteristics and their views.

Main Results:

  • 96.6% of pediatricians favored performing clinical trials in children.
  • Pediatricians with university teaching experience showed reluctance due to concerns about parental stress and adverse events.
  • Pediatricians with prior research experience identified child exploitation as an ethical concern.

Conclusions:

  • French pediatricians generally hold a favorable view towards pediatric clinical trials.
  • Significant concerns regarding parental stress, adverse events, and child exploitation were reported.
  • There is a need for dedicated research ethics education for pediatricians in France.
Abstract

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