Full
Outline
To explore the current application status, implementation considerations, and practical measures for a new model of delivering investigational drugs directly to trial participants (direct-to-subject, DTS) in the context of the revised Good Clinical Practice (GCP) and ICH E6 (R3), with the aim of providing a reference for optimizing its management quality.
Through a literature review, this study compared regulatory policy differences, current implementation status, and common models for the direct-to-subject model between domestic and international settings, and analyze the key considerations for its implementation.
The direct-to-subject model has been adopted both domestically and internationally, but there is a lack of unified implementation guidelines. Its use may be considered when appropriate. Effective implementation can be ensured by strengthening the following aspects: clarification of responsibilities, ethical review, informed consent, risk assessment, qualification verification, training, information system development, risk management, privacy protection, and investigator oversight.
The model aligns with the “patient-centered” philosophy but is still in its exploratory phase. When planning to adopt this approach, its feasibility should be fully demonstrated in the protocol, with enhanced emphasis on ethical review, training, and risk control, while clearly defining the responsibilities of all parties to safeguard participants’ rights and ensure data reliability.
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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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