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Objective: To conduct a research on the current difficulties in the design, evaluation, and implementation of clinical trials of pediatric Chinese medicine and build a list of questions for the development of the Expert Consensus on Issues Related to Clinical Trials of Pediatric Chinese Medicine. Methods: The parties involved in clinical trials of pediatric Chinese medicine were surveyed by online questionnaires to learn the difficulties in the design, evaluation, and implementation of clinical trials. Results: A total of 49 questionnaires were collected, and the experts believed that it was difficult to determine the indications, test purpose, diagnostic criteria, age range, control drugs, efficacy and safety evaluation in the design and evaluation stage of clinical trials of traditional Chinese medicine for children, and there was a lack of scientific basis for developing medication regimen. In the implementation phase, the start time of the trial should be specified, and further improvement should be made in the aspects of ethical review, subject recruitment, informed consent, compliance, and DMC setting. Conclusion: There were many difficulties in the design, evaluation, and implementation of current clinical trials of pediatric Chinese medicines, which should be improved from various aspects such as policy, awareness, and technology, thus to promote the research and development of pediatric proprietary Chinese medicines.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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