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Objectives: This 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. Methods: A 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. Results: A 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. Conclusion: The 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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OBJECTIVES: Our objective was to generate a value set for the SF-6Dv2 using time trade-off (TTO) and a discrete-choice experiment with a duration dimension (DCETTO) in China. METHODS: A large representative sample of the Chinese general population was recruited from eight provinces/municipalities in China, stratified by age, sex, education level, and proportion of urban/rural residence. Respondents completed eight TTO tasks and ten DCETTO tasks during face-to-face interviews. Ordinary least squares (OLS), random-effects, fixed-effects, and Tobit models were used for TTO data, and conditional logit and mixed logit models were used for DCETTO. The monotonicity of model coefficients and the consistency of the predicted values according to intraclass correlation coefficient (ICC), mean absolute difference (MAD), and mean squared difference (MSD) were compared between the two approaches. RESULTS: In total, 3320 respondents (50.3% male; range 18-90 years) were recruited. The random-effects model and the conditional logit model were preferred for the TTO and DCETTO, respectively. The TTO values ranged from - 0.277 to 1, with 927 (4.94%) states considered as worse than dead (WTD). The corresponding range for DCETTO was - 0.535 to 1, with a higher WTD of 8.50%. DCETTO presented minor non-monotonicity with the coefficients in two dimensions. Values from the two approaches were highly consistent (ICC 0.9804, MAD 0.0588, MSD 0.0055), albeit those with DCETTO were slightly lower than those with TTO. The value set generated by TTO was preferred given the better monotonicity and the statistical significance of coefficients. CONCLUSIONS: The Chinese value set for the SF-6Dv2 was established based on the TTO approach, but the DCETTO also performed well. Minor issues of non-monotonicity did present for DCETTO.
