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This study aimed to evaluate analyze the current quality status of investigator-initiated trials (IITs) conducted in a hospital, analyze key influencing factors, explore targeted improvement measures, and provide references for enhancing the design level of IITs.
IITs registered in the Medical Research Registration and Filing Information System by the hospital from January 2020 to April 2025 were selected as the research objects. The research compliance, scientificity, and value were assessed, and then followed by statistical analysis.
Among the 124 IITs, 76% were initiated by investigators with associate senior titles or above. The median scores of the standardization and scientificity dimensions were both 8 points, while the median score of the research value dimension was 6 points. The total scores of interventional studies and observational studies were 23 and 21, respectively (P<0.01), and the total scores of multi-center studies and single-center studies were 23 and 20, respectively (P<0.001). Except for the correlation between funding support and the scientificity score, which the difference was not statistially signifccant (P>0.05), funding support showed a significant positive correlation with both the research compliance and research value dimensions (correlation coefficients ranging from 0.300 to 0.346, all P<0.001); disciplinary strength, and investigator title were significantly positively correlated with all three dimensions of research quality (correlation coefficients ranging from 0.213 to 0.380, P<0.01, P<0.001) and disciplinary strength had the greatest impact on research value.
Medical institutions still need to strengthen the standardization and scientificity of IITs, and there is great room for improvement in research value. Disciplinary strength, investigator background, and funding support are key factors affecting the research quality. From the perspective of institutional management, the quality of IITs can be effectively improved by constructing a systematical management system that integrates scientific review, methodological support and resource guarantee.
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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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