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.