Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

Song, Lin; Jia, Yuntao; Ran, Suzhen; Li, Bin; Xu, Jianhua; Huo, Bennian; Yin, Nange; Ai, Mao-lin; Liu, Yao

doi:10.1186/s12887-022-03208-2

Cited by 7 publications

(6 citation statements)

References 27 publications

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“…Most of the RCTs were initiated by tertiary hospitals, which is consistent with the distribution of economic prosperity, but there is still a large uneven geographical distribution of the sponsors and the research institutions. Additionally, most of the studies analysed paediatric clinical trials conducted in China, and the results were consistent with our previous study [ 26 , 27 ]. Another previous study also revealed disparities in the global distribution of orthopaedic RCTs, with the majority of the trials originating from the United States, the United Kingdom and Canada, and this global disparity has not improved over the last decade [ 35 ].…”

Section: Discussionsupporting

confidence: 90%

“…In that study, the common reasons for trial discontinuation were commercial or strategic decisions [84 (26.9%)] and futility/lack of efficacy [70 (22.4%)] [ 26 ]. In 2022, we analysed paediatric clinical trials conducted in China and reported that the current challenge was the further development of dosage forms suitable for children with special attention to neonates and premature infants and the improvement of the uneven geographical distribution of sponsors and researchers [ 27 ].…”

Section: Introductionmentioning

confidence: 99%

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Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

Huo,

Xu,

Liu

et al. 2024

BMC Pediatr

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Background Randomized controlled trials (RCTs) are usually the basis of evidence-based medicine, but whether the results of RCTs can be correctly translated into clinical practice depends on the quality of the literature reported. In this study, we evaluated the general characteristics and quality of paediatric RCTs published in China to provide evidence for the reporting of paediatric RCTs and their application in clinical practice. Methods We conducted a cross-sectional observational study of paediatric RCTs published in paediatric journals in China between January 1, 1999, and December 30, 2022. All RCTs that included children (younger than 18 years old) were retrieved, and the general characteristics of the RCTs were extracted and analysed. The quality of the RCTs was assessed by the Cochrane quality assessment protocol. Results After screening 20 available paediatric journals, 3545 RCTs were included for analysis. The average annual growth rate of the number of published paediatric RCTs from 1999 to 2022 was 7.8% (P = 0.005, R2 = 0.311). Most of the studies were carried out in East China [1148 (32.4%]; the centres of the RCTs were mainly single-centre [3453 (97.4%], and the interventions were mainly medication [2442 (68.9%)]. Comparing RCTs published in 2017–2022 with RCTs published in 1999–2004, the quality of RCTs significantly improved in terms of random sequence generation, allocation concealment, blinding participants and personnel, incomplete outcome data and selective outcome reporting. RCTs published in multiple centres from the Chinese Science Citation Database were identified, and the approval of the ethics committee was of better quality for all the analysed risk of bias items. Conclusion The number and quality of paediatric RCTs reported in China have improved in recent years, but the overall quality was relatively low. Special attention should be given to allocation concealment and blinding outcome assessment, and dropouts, adverse effects and sample size calculations should be reported. Promoting government policies, strengthening the standardization of journal publishing and advancing the registration of clinical trials are feasible measures.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

Huo,

Xu,

Liu

et al. 2024

BMC Pediatr

Self Cite

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“…The absence of paediatric clinical trials has resulted in limited or no documentation for paediatric use of many approved drugs, leading to insufficient information on drug labels commonly prescribed for children. A cross-sectional observational study of paediatric trials registered in the Drug Trial Registration and Information Publication Platform from 2013 to 2021 displayed that there were 588 registered paediatric clinical trials in China, which accounted for 3.9% of the total registered trials [ 34 ]. While 638 in Brazil, there were 833 registered paediatric clinical trials, accounting for 17.9% of the total registered trials ( https://clinicaltrials.gov/ ).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil

Li,

Cheng,

Zhang

et al. 2024

Health Res Policy Sys

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Objective This work compares the marketing authorization, labels and dosage forms of medicines in the WHO Model List of Essential Medicines for Children (EMLc) in China, the Russian Federation and Brazil to urge policymakers to pay more attention to paediatric medication. Methods Medicines were selected from the 8th EMLc. By searching relevant databases, which include different types of medical information in China, the Russian Federation and Brazil, the marketing authorization, labels and dosage forms of paediatric medicines in the three countries were evaluated. Results A total of 485 drug products containing 312 active pharmaceutical ingredients listed in the WHO EMLc were evaluated. Among them, 344 products were approved for use in China, 286 in the Russian Federation and 264 in Brazil. Out of the 344 approved medicines, 317 (92.15%) were authorized for paediatric use in China, 224 (78.32%) in the Russian Federation and 218 (82.58%) in Brazil. In terms of guidance information labelling on drug labels, 75.08%, 83.04% and 88.07% of paediatric drugs approved in China, the Russian Federation and Brazil, respectively, clearly indicated the usage and dosage for paediatric use. Additionally, injections and tablets were the most prevalent dosage forms in these three countries. Conclusion There is still scope for enhancing the marketing authorization and development of dosage forms for paediatric medicines in the three countries. Furthermore, additional measures are being implemented to enhance the information provided on drug labels for children, particularly in China.

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“…Also, the newly discovered drugs for diabetes and dyslipidemia have been confirmed with definite cardiovascular benefits, which also suggested that the drug therapy of cardiometabolic diseases should be considered as a whole instead of separate diseases. Regarding the clinical trials of drugs in China, several relevant analyses and evaluations have been conducted in the fields of lung cancer, endocrine disorder, liver disease, etc [ 8 , 11 , 27 , 28 ]. However, the clinical trials of cardiometabolic diseases in China and their changes have not been fully concerned and discussed.…”

Section: Discussionmentioning

confidence: 99%

The changing landscape of drug clinical trials on cardiometabolic diseases in China, 2009–2021

Hao

Zheng

et al. 2023

Diabetol Metab Syndr

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Background Cardiometabolic disease is a clinical syndrome characterized by multiple metabolic disorders, with atherosclerosis as the core and cardiovascular and cerebrovascular events as the outcome. Drug research and development (R&D) in cardiometabolic diseases has grown rapidly worldwide. However, the development of cardiometabolic drug clinical trials in China remains unclear. This study aims to depict the changing landscape of drug clinical trials for cardiometabolic diseases in China during 2009–2021. Methods The detailed information of drug trials on cardiometabolic diseases registered in the National Medical Products Administration (NMPA) Registration and Information Disclosure Platform was collected between January 1, 2009, and July 1, 2021. The landscape of cardiometabolic drug clinical trials was analyzed by the characteristics, time trends, indications, pharmacological mechanisms, and geographical distribution. Results A total of 2466 drug clinical trials on cardiometabolic diseases were extracted and analyzed. The annual number of drug trials increased rapidly in the past twelve years. Among all the trials, the bioequivalence trials (1428; 58.3%) accounted for the largest proportion, followed by phase I (555; 22.5%), phase III (278; 11.3%), phase II (169; 6.9%), and phase IV (26; 1.1%). Of 2466 trials, 2133 (86.5%) trials were monomer drugs, only 236 (9.6%) trials were polypills and 97 (3.9%) were traditional Chinese medicine (TCM) compounds. In terms of pharmacological mechanisms, the number of trials in dihydropyridine (DHP) calcium antagonists 321 (11.9%) ranked first, while trials in angiotensin receptor blocker (ARB) 289 (10.7%) and dipeptidyl peptidase-4 (DPP-4) inhibitor 205 (7.6%) ranked second and third place respectively. Of 236 chemical polypills trials, 23 (9.7%) polypills were the combination of DHP calcium antagonists and statins, while others were the combination of two same pharmacological effect agents. As for the geographical distribution of leading units, 36 trials were led by principal investigators (PI) units from Beijing, followed by Jiangsu (n = 29), Shanghai (n = 19), Guangdong (n = 19), and Hunan (n = 19), showing an uneven regional distribution. Conclusions Great progress has been made in drug clinical trials on cardiometabolic diseases, especially in antihypertensive agents, hypoglycemic agents, and hypolipidemic agents. However, the insufficient innovation of first-in-class drugs and polypills should be carefully considered by all stakeholders in drug trials.

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Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

Cited by 7 publications

References 27 publications

Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil

The changing landscape of drug clinical trials on cardiometabolic diseases in China, 2009–2021

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