Assignment task:
A recurring ethical issue in the pharmaceutical industry is the exclusion of vulnerable populations, such as pregnant women, from clinical trials due to ethical and safety concerns. This exclusion creates significant gaps in understanding the safety, efficacy, and appropriate dosages of drugs for these populations. Pregnant women, in particular, face unique challenges, as drug testing must balance the well-being of both the mother and the fetus. Ethical concerns such as potential harm to the fetus, the complexity of dual protection, and the risk of coercion due to limited treatment options further complicate trial designs. As a result, many drugs are marketed without adequate data, exposing pregnant women and their unborn children to preventable risks. To address the ethical challenges of including pregnant women in drug testing, preclinical research can utilize advanced modelling techniques, such as physiologically based pharmacokinetic (PBPK) models and animal studies, to assess drug behaviour and effects on pregnancy. Ethical clinical trial designs, such as adaptive trials, micro-dosing studies, and trimester-specific trials, can minimize risks while gathering valuable safety and efficacy data. Additionally, real-world evidence from pregnancy registries and post-marketing surveillance provides critical insights into drug use during pregnancy, ensuring safety and informed decision-making without exposing participants to unnecessary risks. Respond to this discussion. Need Professional Help?