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