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Off-label use of drugs in pediatrics: a scoping review
To explore the current state of research on off-label drug use in children and identify the existing research gaps in this topic. Six literature databases were searched to identify studies focusing exclusively on off-label drug use in children (aged < 18 years) published in Chinese or English between 2016 and 2021. We also searched clinicaltrials.gov for pediatric clinical trials conducted in the same period and compared the numbers of studies on off-label use and clinical trials for the most commonly reported drugs and drug types. Our search revealed 568 studies on off-label drug use. Almost half of the studies (n = 240) were cross-sectional. A total of 212 specific drugs or drug types were addressed in 361 studies, the most frequent being antipsychotic agents (n = 12), dexmedetomidine (n = 10), and rituximab (n = 8). Antipsychotic agents were also the most common type of drug examined in clinical trials in children. We identified a total of 435 different types of off-label use, the top three being unapproved indication (n = 157), population (n = 96), or age (n = 36). Only about one-third of the studies reported collecting informed consent (n = 195) or having ethics committee approval (n = 166). Conclusions: Off-label use of antipsychotics in children is widely reported in the literature. We suggest pediatric researchers to consider the number of studies on off-label use and existing clinical trials on different drugs when selecting target drugs for new studies and systematic reviews. What is Known: center dot There exist a large number of studies on off-label drug use in children. What is New: center dot This is the first scoping review of studies on off-label drug use in children. center dot Off-label use of antipsychotic agents is widely reported.
期刊论文
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Clinical Epidemiology in China series. Paper 1: Evidence-based medicine in China: An oral history study
Objective: To describe and record the evolution of EBM in China. Study Design and Setting: We conducted the study following the general methodology of oral history. The interviews were done at Lanzhou University, between 18th and 22 nd April 2019 using pre-defined questions. All interviews were videorecorded. Two investigators extracted and analyzed the information from the interviews independently. Results: One international expert and ten Chinese experts participated in the interviews. After the introduction of EBM in China in the mid-1990s, more than 20 EBM centres have been established. According to the interviewees, Gordon Guyatt, David Sackett and lain Chalmers are the international experts who played the most important role in the development of EBM in China. China has contributed to EBM on the international level by conducting systematic reviews, developing reporting checklists, and introducing the principles of EBM into Traditional Medicine. The Chinese Cochrane Centre and the EBM Centre of Lanzhou University were ranked the top two EBM Centres in China by the interviewees. Conclusion: EBM has been developing in China for nearly a quarter of a century. Many achievements have been reached, however, EBM is still facing many challenges in China, including shortages of funding support and personnel, as well as limited local high-quality evidence. (C) 2021 Elsevier Inc. All rights reserved.
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