Registered Clinical Trials Comprising Pregnant Women in China: A Cross-Sectional Study

Abstract

Background: In this study, an investigation was conducted on clinical drug trials comprising pregnant women in China that provided data on the quantity, properties, source of funding, and geographical distribution regarding registration and post-marketing studies.Methods: We conducted a cross-sectional descriptive study of clinical trials of pregnant women in China on 30 December 2021, and it was registered on the official Drug Clinical Trial Information Management Platform (ChiCTR) (http://www.chinadrugtrials.org.cn) established by the State Food and Drug Administration of China (Chinese FDA).Results: This study encompassed 72 registered trials (0.46%, 72/15,539) for data analysis. Of these trials, 43.1% of trials were started between 2013 and 2016, and nearly half of the trials (48.6%) were completed. Industries were listed as the primary sponsor for 95.8% trials. Economically developed eastern China and northern China, accounting for 69.5% of the 72 registered trials, were the most frequently identified study locations. Regarding study designs of these trials, more than half of the trials (70.8%) were randomized, 61.1% were a parallel assignment, 33.3% were phase 3, and half of the trials (54.2%) were open label. In total, 23 trials met the requirements after excluding trials of cancer and/or of postmenopausal women, accounting for 0.15% of the 15,539 registered trials in the ChiCTR websites. Of the 72 clinical trials, 54 drugs for 18 indications were included. Of these indications, the highest proportion of the trials is osteoporosis (27.8%), followed by cancer (22.2%), assisted reproduction (13.9%), and other indications (13.9%).Conclusion: This survey revealed a significant shortage of the development, evaluation, and safety trials of pregnancy-related drugs in China. Modifying or adding legislation and providing financial incentives may therefore encourage pharmaceutical companies to conduct additional clinical trials on pregnant women.

Lipid nanoparticle structure and delivery route during pregnancy dictates mRNA potency, immunogenicity, and health in the mother and offspring

“…Safety data are scarce because pregnant people have been commonly excluded from clinical trials (4). As of 2022, some international clinical trial registries report that pregnant people were included in a mere 0.15% of registered clinical trials (5). Because of lack of safety data, many commonly used drugs, including the analgesic ibuprofen, the antidepressants clonazepam and lorazepam, the antimalarial primaquine, and the antibiotics ciprofloxacin, levofloxacin, and trimethoprim are restricted during pregnancy (6).…”

Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes

“…On average, 27 years are needed to assign a precise risk category to a medicine (Adam et al, 2011), and research to gain more information on the safe use of medicines in pregnancy is challenging. Pregnant women are commonly excluded from clinical trials assessing the efficacy and safety of new medicinal products (Shields and Lyerly, 2013; Scaffidi et al, 2017; Zhao et al, 2022). As soon as a product is on the market, marketing authorisation holders (MAHs) are involved in the continuous monitoring of medication safety in pregnancy via post-marketing surveillance, including spontaneous reporting and (mandatory) product-specific pregnancy registries.…”

Lipid nanoparticle structure and delivery route during pregnancy dictate mRNA potency, immunogenicity, and maternal and fetal outcomes

“…Safety data are scarce because Pr people are commonly excluded from clinical trials ( 4 ). As of 2022, international clinical trial registries report that Pr people were included in a mere 0.15% of registered clinical trials ( 5 ). Because safety data are lacking, many commonly used drugs, including the analgesic ibuprofen, antidepressants (e.g., lorazepam), and antibiotics (e.g., ciprofloxacin), are contraindicated during pregnancy ( 6 ).…”