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.