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To explore the consideration on the key techniques of clinical trial design of drugs for the treatment of atopic dermatitis.
By summarizing the clinical research status of drugs for the treatment of atopic dermatitis, and investigating the progress of technical guidelines for the drugs in China and abroad in recent years, relevant technical considerations are proposed based on the China's experience in Drug R&D and the process of review.
The design of whole clinical trial of drugs treating atopic dermatitis should be based on the characteristics of the disease and investigational drug, the purpose of the study. Clinical trials for pediatric patients should be conducted as early as possible under the premise of prior research evidence and ensuring the safety of subjects. The appropriate study population should be selected, and a series of key elements, such as control drugs, efficacy and safety indicators, study period, etc., should be reasonably set up in the clinical trial design, in order to assist the scientific research and the development of the drugs. The positioning of the study population should be based on the drug action mechanism and drug effect intensity, and the patients with corresponding severity should be selected. The efficacy of the study should be comprehensively evaluated to assess the improvement of skin lesions, symptoms, quality of life, etc., and attention should be paid to the efficacy and safety of the study when used in pediatric patients as well as in long-term treatment.
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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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