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.