Cover Letter
Dear Editors:
We would like to submit the enclosed manuscript entitled “Survey of Registered Clinical Trials in Pregnant Women in China ”, which we wish to be considered for publication in “British Journal of Clinical Pharmacology ”.
In this work, we evaluated the first report of China about pregnant drug trials and provided robust data on the number, location, funding source and therapeutic area of drug trials in pregnancy. It was suggested that further research efforts should increase awareness among obstetricians and pregnant women and add legislative and fiscal incentives to inspire attention on pregnant drug clinical trials. I hope this paper is suitable for “British Journal of Clinical Pharmacology ”.
No conflict of interest exits in the submission of this manuscript, and manuscript is approved by all authors for publication. I would like to declare on behalf of my co-authors that the work described was original research that has not been published previously, and not under consideration for publication elsewhere, in whole or in part. Now the manuscript is submitted online, and I look forward to hearing from you.
Yours Sincerely,
Yi ZHAO
Department of Drug Clinical Trials,
Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310006, China.
Tel.: +86-13858004811
Fax: +86-571-89992206
Email: zhaoyi1124@zju.edu.cn
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.
Keywords: Clinical trials, pregnant women, drug development, drug safety, drug innovation, sources of funding,geographical distribution, registration and post-marketing studies, legislation and financial incentives