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Analysis of regulatory strategies for remote decentralized clinical trials
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Bo SUN, Yi-feng CHEN, Gang LI
Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(6) : 436 - 441
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Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(6): 436-441
• Policy and Management •
Analysis of regulatory strategies for remote decentralized clinical trials
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Bo SUN, Yi-feng CHEN, Gang LI
Affiliations
  • Shanghai Center for Drug Evaluation and Inspection, SHANGHAI 201203, China
Published: 2024-06-25 doi: 10.14109/j.cnki.xyylc.2024.06.08
Outline
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Traditional clinical trials are often expensive, relatively inefficient, and may also cause additional burden for trial participants. The use of new technologies and methods in remote decentralized clinical trials (DCT) can help to improve clinical trials efficiency. The application of DCT brings several benefits, but also poses new challenges for the regulation of clinical trials. In this study, the current situation and issues surrounding the use of digital technology in clinical trials were analyzed, as well as the regulatory practices and regulatory scientific research on DCT in Europe and the United States. The proposed regulatory strategies for DCT in China were investigated, taking into account the current development and regulatory considerations of DCT in China.

remote decentralized clinical trials  /  regulatory science  /  techniques, aministrative  /  digital technology
孙搏, 陈一飞, 李刚. 远程智能临床试验的监管策略分析. 中国新药与临床杂志, 2024 , 43 (6) : 436 -441 . DOI: 10.14109/j.cnki.xyylc.2024.06.08
Bo SUN, Yi-feng CHEN, Gang LI. Analysis of regulatory strategies for remote decentralized clinical trials[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (6) : 436 -441 . DOI: 10.14109/j.cnki.xyylc.2024.06.08
Year 2024 volume 43 Issue 6
651
332
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Article Info
doi: 10.14109/j.cnki.xyylc.2024.06.08
  • Receive Date:2023-05-12
  • Online Date:2026-03-20
  • Published:2024-06-25
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History
  • Received:2023-05-12
  • Accepted:2024-03-06
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    Shanghai Center for Drug Evaluation and Inspection, SHANGHAI 201203, China
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表12种不同金属材料的力学参数
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Family
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Number of
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Number of
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Number of
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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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