Inclusion of Pregnant Women in Clinical Trials: Need, Ethical and Scientific Considerations and Current Status

Abstract

This article summarizes all aspects related to the exclusion and inclusion of pregnant women in clinical trials. Historically to date, pregnant women were observed as most excluded population from clinical research. There are various scientific as well as ethical reasons behind their exclusion. However, given the burden of various illnesses and diseases during pregnancy, there is a need to include them in clinical research. Available data regarding safety and efficacy of medicinal products were also collected from accidental exposure. But these evidences are insufficient to give results. Various ethical aspects and scientific reasons are also given proper evidences to include pregnant women in clinical trials. In this review, we have summarized data from clinicaltrials.gov.in on completed clinical trials exclusively on pregnant women and ongoing clinical trials in pregnant women to find out the current status of pregnant women in clinical research. There is a need to consider designing of clinical trials in pregnant women in such a way that fear of any harm should be overcome, such that more pregnant women can participate in clinical trials.