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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.
Introduction:
There is a crucial need to perform clinical trials in pediatrics due to an increased prescription rate of unapproved drugs. Since pediatricians are the gatekeepers of clinical trials, the primary objective of the current study was to evaluate, for the first time in France, pediatricians' views on performing clinical trials. The second objective was to identify the factors that influence their perceptions.
Material And Methods:
In 2017, pediatricians who were members of the French Pediatric Society completed an online survey comprising 27 questions. Fisher's exact test was performed to evaluate possible correlations between pediatrician characteristics (age, sex, parenthood, professional experience, status, type of practice, previous participation in clinical trials, ethics education) and personal views on clinical trials. A value of P≤0.001 was considered statistically significant.
Results:
Overall, 207 pediatricians completed the questionnaire. Almost all participants (96.6%) were in favor of performing clinical trials. Pediatricians with teaching experience at university hospitals were more reluctant to propose children's participation in clinical trials for fear of increasing parental stress (P<0.001), or the occurrence of serious adverse reactions (P<0.001). Pediatricians with coordinator or investigator experience considered that one of the ethical drifts in pediatric clinical trials is the risk of child exploitation (P<0.001).
Conclusion:
Our findings suggest a favorable position of pediatricians concerning clinical trials, despite numerous concerns. Another outcome is the need to create an educational system of research in ethics in France dedicated to pediatricians in order to guarantee good clinical practice in research.
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