Principal Findings
In this clinical trial registration analysis, reliable data on the quantity, location, source of funding and therapeutic area of the trials on pregnancy related drugs were provided, thus to demonstrate that in China, pregnant women are the population that is also always excluded from clinical trials. To the best of our knowledge, this study is the first report regarding drug trials in pregnant women in China, although this finding is consistent with what reported by other foreign countries. All of these reports considered pregnant women as ”drug orphan”23-25. Even when the number of pregnant women is sufficient, the number of clinical trials in pregnant women registered in China is very low compared to the regions and countries(e.g. North Africa/Middle East, Europe, America) where the trials on pregnancy related drugs are relatively active as indicated by J Scaffidi15. This may be related to study culture, sponsor’s bias, and drug development trends.
In the past few decades, neither the investigators nor the patients were very enthusiastic to participate in clinical trials. Our study found that since the establishment of the NMPA registration platform in 2013, the total number of drug clinical trials registered on the platform and the CHiTR platform is 44,505, which is only 1/5 of the number of valid clinical trials on international registration platform within a year. Our study results also showed that the number of trials for new drugs and the assessments of efficacy and safety of the drugs for treatment of common pregnancy conditions are clearly insufficient. Similarly, there were no PK studies in pregnant women. This is possibly because that both the public and healthcare providers are worrying about the teratogenicity and other negative impact of the investigational drugs on the fetal development, rather than about the mother26. These data shows that the introduction of new drugs to pregnant women population will be complex.The mainstream prescribed drugs for pregnant women will still be off-label and the information, such as dosage, efficacy and safety for pregnant women, is insufficient.