The evolution of ethical and legal regulations of drug research

Patient safety and the ethical frameworks governing clinical trials are crucial challenges in drug development. Historical analysis reveals that advances in pharmacology often occurred in the context of insufficient protection for vulnerable populations. In this review, we outline how past abuses in medical research led to the establishment of informed consent, ethical oversight, and patient rights within modern regulatory frameworks. We trace the evolution of clinical trial regulations and drug quality standards from the 19th century onwards, highlighting the influence of pharmaceutical companies, regulatory bodies, and international organisations. We also emphasise how historical conflicts among therapeutic innovation, commercial interests, and public trust have influenced the mechanisms for evaluating drug safety, efficacy, and quality, particularly amid the emergence of new biomedical technologies.