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Setting of the run-in period and its application in clinical trials
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Fang HAN1, 2, Bao-li LIU1, Ke-gang CAO2, 3, Ying GAO2, 3
Chinese Journal of New Drugs | 2023, 32(14) : 1406 - 1410
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Chinese Journal of New Drugs | 2023, 32(14): 1406-1410
Setting of the run-in period and its application in clinical trials
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Fang HAN1, 2, Bao-li LIU1, Ke-gang CAO2, 3, Ying GAO2, 3
Affiliations
  • 1Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
  • 2Institute for Brain Disorders Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • 3Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China
Published: 2023-07-30
Outline
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The run-in period is a specific stage after enrollment and before randomization. It is an important design element of many landmark drug clinical trials and plays an important role in drug development. However, the status quo includes non-standard design of run-in period in research protocols and inadequate reporting of run-in period in results. The author summarize the definition, type, duration, significance, advantages and disadvantages of the run-in period, and list clinical application cases, in order to provide reference for the clinical trial design and the application of the run-in period.

run-in period  /  randomized controlled trial  /  clinical trial design
Fang HAN, Bao-li LIU, Ke-gang CAO, Ying GAO. Setting of the run-in period and its application in clinical trials[J]. Chinese Journal of New Drugs, 2023 , 32 (14) : 1406 -1410 .
Year 2023 volume 32 Issue 14
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Article Info
  • Online Date:2026-03-05
  • Published:2023-07-30
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History
  • Accepted:2022-11-04
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Affiliations
    1Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
    2Institute for Brain Disorders Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
    3Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China
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Number of
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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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