Risk and benefit
Globally, there is a lack of representative studies on pregnancy drugs
and pharmaceutical companies are not willing to develop new drugs or
carry out clinical trials in pregnant women without explicit legislation
or government incentives. Our findings suggested that the pharmaceutical
industry being as sponsors accounts only for 10.3% (12/117) , which is
significantly lower than other pharmaceutical fields. This is consistent
with the results of some previous analysis on sponsorship regarding
pregnancy drug trials1,23,24. This also indicated that
studies on pregnant women may require government’s intervention,
subsidy, incentive, and making advancement27. Our
analysis also showed that almost all trials sponsored by pharmaceutical
companies are for labor induction or post-partum adjuvant therapy.
Possible litigation discourages them to use medicines indicated for
general pregnancy conditions or for use in the first trimester of
pregnancy. Similarly, it is not hard to see why this survey showed
analgesia and anesthesia are the mostly focused therapeutic areas in
pregnancy-related clinical trials. Apparently, the time of
administration of these drugs and their effects on the fetus are short.
Interestingly, the 5 new drugs under investigation are merely the ones
being structurally modified, of with change in dosage form or in
administration methods, which are the typical way of drug research and
development the pharmaceutical companies adopt to avoid risks. Almost
one-third of the trials only evaluated the marketed drugs for which a
pregnancy prescription has not been approved. It was thought to be a way
to reduce the investment and complicated process of new drug
development. Similarly, purchasing drug clinical trial liability
insurance is another way for the sponsors to avoid the risk of
litigation and compensation.