Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children

Mulberg, Andrew E.; Cripps, Timothy

doi:10.1016/j.curtheres.2019.01.006

Cited by 3 publications

(1 citation statement)

References 11 publications

(12 reference statements)

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“…Problems such as difficulty recruiting subjects, weak cooperation in joining the group, high risk of falling off, and many unexpected reactions cause multiple challenges for the randomized parallel controlled trial ( 22 ). When conducting an ethical review of pediatric drug clinical trials in children's hospitals, we should not only pay attention to the risk factors that are not often considered in adult trials but also keep track of the review, increase the frequency of the review, and grasp the ethical risks ( 23 ) so as to protect the rights and interests of children and help to achieve the goals of pediatric drug clinical trials smoothly.…”

Section: Discussionmentioning

confidence: 99%

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

Yang,

Jiang,

Bai

et al. 2024

Front. Med.

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ObjectivesThis study aimed to gain insights into pediatric clinical trials conducted in children's hospitals in China and provide valuable references for the development of children's hospitals and the research and development of pediatric drugs.MethodsA comprehensive search was performed on the Chinese Clinical Trial Registry (Chi CTR) and ChinaDrugTrials.org.cn to collect information on all clinical trials involving subjects under 18 years, including those conducted in children's hospitals. The retrieval period was extended until 31 December 2022.ResultsA total of 459 pediatric clinical trials were collected, comprising 299 from Chi CTR and 160 from the Drug Clinical Trial Registration and Information Publicity Platform (Information Platform). Post-marketing drug studies and phase III clinical trials accounted for the majority of research stages. These trials covered a wide range of diseases/systems, with a particular focus on respiratory system disorders, tumors, endocrine disorders, and nutritional or metabolic diseases. Chemical drugs constituted the most extensively studied category, while traditional Chinese medicine/natural drugs received comparatively less attention. Clinical trial activities were primarily geographically focused on the eastern coastal regions of China, with multicenter trials being the most predominant. Ethics committee approval was obtained for 427 studies.ConclusionThe pediatric clinical trials conducted by children's hospitals in China have shown an overall upward trend; however, there is limited research focusing on traditional Chinese medicine, along with significant regional and institutional imbalances. Furthermore, there is still room for improvement regarding ethical review processes. It is recommended that children's hospitals enhance their scientific research capabilities while optimizing resource allocation to meet medical service demands effectively. Additionally, fostering more research-focused children's hospitals will contribute to the high-quality development of children's health in China.

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Section: Discussionmentioning

confidence: 99%

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

Yang,

Jiang,

Bai

et al. 2024

Front. Med.

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Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines

Wollmer

Ungell

Nicolas

et al. 2022

Advanced Drug Delivery Reviews

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Structural Analysis and Assessment of the Rationality of Prescribing Drugs in Pediatric Practice

L.I.,

E.E.,

M.M.

et al. 2023

Mediko-farmacevtičeskij žurnal "Pulʹs"

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This article discusses the problems of providing drug care to children. The aim of the work was to identify the prerequisites for the creation of a Russian indicative list of medicines for children based on the assessment of rationality and structural analysis of drug prescriptions in pediatric practice. The study used the methods of content analysis, statistical analysis, graphical method. The sample consisted of 2,900 prescriptions for drugs and other pharmacy products made by doctors of various profiles to children aged 0 to 17 years. The study showed that 92% were medicines (MP), the rest - other pharmacy products (biologically active additives, cosmetics, medical products, etc.). An analysis was also carried out by the frequency of prescriptions, by dosage forms, by anatomical-therapeutic-chemical (ATC) classification and by prescriptions outside the instructions (off-label, in our study, we attributed to off-label those cases when drugs were prescribed to children aged , not officially permitted in the instructions for medical use). Nurofen for children (Ibuprofen) oral suspension was the most frequently prescribed medication in the study sample. When analyzing according to the first level of the ATC classification, the largest percentage of prescriptions fell on group R - "Respiratory system". From the sample studied by us, most often children were prescribed drugs in liquid dosage forms, namely, drops for oral administration, in off-label prescriptions, for the most part, solid dosage forms (tablets) were found. It was found that in most cases drugs were prescribed outside the instructions for children aged 1 to 3 years - 39% of all off-label prescriptions. In our opinion, to improve the pharmaceutical care provided to children, it is necessary to create a Russian indicative list of essential medicines for children, which should be periodically reviewed and republished in order to contain only relevant and reliable information.

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Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children

Abstract: Highlights Stakeholders must work collaboratively. Efforts to address off label use of drugs through the drug approval regulatory pathway should be the goal. Children should not be exposed to unnecessary clinical trials.

Cited by 3 publications

References 11 publications

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines

Structural Analysis and Assessment of the Rationality of Prescribing Drugs in Pediatric Practice

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