Ethical Preparedness of Developing Nations in the Age of Decentralized Clinical Trials: Comparative Overview of South Asian Regulation.

The advent of decentralized clinical trials (DCTs) has altered the usual trends in clinical trials, and this presents an ethical, regulatory, and operational dilemma, particularly to the low-and middle-income countries (LMICs). This review critically examines the ethical preparedness of countries in South Asia to transform to the DCT paradigm. We consider the readiness of such nations as India, Bangladesh, Pakistan, Sri Lanka, Nepal, Bhutan, and the Maldives by weighing the local regulatory environments and establishing a difference in ethical safeguards, cyber infrastructure, and protection of participants. The paper specifically focuses on some of the fundamental themes, including the concept of informed consent in the virtual world, data security, the digital literacy problem, and the evolving nature of the local ethics committees. Case studies allow us to identify systemic gaps, especially the ones that were provoked by the COVID-19 pandemic, and propose ways to harmonize ethics with the comparative regulatory matrix. The focus is on regionalization of international standards, including ICH-GCP, and intergovernmental cooperation, as well as the effective construction of strong and inclusive systems of governance. This review offers strategic suggestions that policymakers may implement to enhance ethical resilience in the South Asian passage to a decentralized, data-driven future of clinical research.