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Survey of Registered Clinical Trials in Pregnant Women in China
  • +4
  • yi zhao,
  • xiaofei luan,
  • hui yang,
  • guiping du,
  • qiongguang zhang,
  • zhengfu zhang,
  • subiao wang
yi zhao
Zhejiang University School of Medicine Women's Hospital
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xiaofei luan
Zhejiang University School of Medicine Women's Hospital
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hui yang
Device Evaluation Center Zhejiang Medical Products Administration
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guiping du
Zhejiang University School of Medicine Women's Hospital
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qiongguang zhang
Center for Food and Drug Inspection of NMPA
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zhengfu zhang
Center for Food and Drug Inspection of NMPA
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subiao wang
Zhejiang Medical Products Administration
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Abstract

Objective: To investigate the drug clinical trials in pregnant women in China to provide data on the quantity, properties, source of funding and geographical distribution for the registration and post-marketing studies. Methods: We collected data of 10865 clinical trials from the Drug Clinical Trial Registration and Information Disclosure Platform and 33649 clinical trials from Chinese Clinical Trial Registry (ChiCTR) performed on pregnant women between January 2013 and June 2020. Retained trials were analyzed based on several key variables (e.g., study endpoints, sources of funding, area of interest). Results: The percentage of trials regarding pregnancy registered to be carried out in China was 0.26%, where the percentage of trials for new drug applications was 0.27%. Most trials focused on anesthesia/analgesia, infections, and endocrine disorders. In the analyzed trials, most (72.6%,85/117) were designed using randomized parallel or cross-over grouping, and 59.8% (70/117) of which put the health of the mother or fetal as the primary endpoint. There were no pre-planned pharmacokinetic studies in pregnant women. Only 5 new investigational drugs were developed for delivery and postpartum related treatments. The geographic distribution of the study sites was obviously uneven, with higher number of sites being distributed in the southeast of China (50 [41%]). Conclusion: This survey showed that in China, there is a significant shortage in the development, evaluation and safety trial of pregnant drugs. Modifying or adding legislation and financial incentives may encourage the pharmaceutical companies to carry out clinical trials in pregnant women.