Open AccessResearch conducted on gestating women globally during trials
Author(s) -
Sunil Chaudhry,
Vishwas Sovani
Publication year - 2022
Publication title -
indian journal of pharmacy and pharmacology
Language(s) - English
Resource type - Journals
eISSN - 2393-9087
pISSN - 2393-9079
DOI - 10.18231/j.ijpp.2021.054
Subject(s) - pregnancy , clinical trial , medicine , human immunodeficiency virus (hiv) , diabetes in pregnancy , inclusion and exclusion criteria , tuberculosis , intensive care medicine , alternative medicine , clinical research , gestation , family medicine , pathology , biology , gestational diabetes , genetics
The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.