Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs

AbstractEvidence-based treatment for pregnant women will ultimately require research conducted in the population of pregnant women. Currently, few scholars have addressed the issue of responsible inclusion of pregnant women in drug research. Because of additional risks associated with including pregnant women in drug research and the altered ways in which drugs are processed by the pregnant body, pregnant women cannot be treated as an ordinary subgroup in the various phases of drug development. Instead, responsible inclusion of pregnant women requires careful design and planning of research for pregnant women specifically. Knowledge about these aspects is virtually nonexistent.In this article, we present a practical framework for the responsible inclusion of pregnant women in drug development. We suggest that the framework consists of using a question-based approach with five key questions in combination with three prerequisites which should be addressed when considering inclusion of pregnant women in drug research. The five questions are:Can we consider the drug safe (enough) for first exposure in pregnant women and fetuses?In which dose range (potentially depending on gestational age) can the drug be considered to remain safe in pregnant women?At what dose (regimen, within the range considered safe) can we expect efficacy in pregnant women?Can efficacy be confirmed at the target dose, either similar to the initial population or different?Can clinical safety be confirmed at ...

Source: Trials - February 20, 2018 Category: Research Source Type: clinical trials