Geographical distribution
Our conclusion showed that the geographical distribution of study sites
with pregnant women is significantly uneven, which is common in China.
The study sites where many drug trials in pregnant women were conducted
are tertiary hospitals in developed cities. This geographical difference
was due to the uneven distribution of higher level of clinical trial
institutions, rather than the uneven distribution of
patients35. According to guidelines issued by NMPA on
May 11, the clinical trial agency certification system will be replaced
by a new records management system. Before carrying out a clinical trial
at an eligible medical institution, simply register on the
NMPA-authorized website. The purpose is to promote the formation of a
highly positive medical innovation environment36. At
the same time, the pharmaceutical companies, ethics committees and CROs
will take more responsibility in the clinical trials.