Abstract

ANALYSIS OF CLINICAL TRIAL REQUIREMENTS FOR CANCER DRUGS IN INDIA AND THE USA WITH INTEGRATION OF AI APPLICATIONS

Hemant Verma*, Dr. Gurmeet S. Chhabra, Dr. Nimita Manocha

ABSTRACT

With a fast rising burden in both developed and developing countries, cancer continues to be a major cause of illness and death worldwide. Disability-adjusted life years (DALYs) associated with cancer are expected to increase dramatically in India, whereas high incidence and death rates are still reported in the US despite sophisticated healthcare systems. This increasing burden emphasizes the necessity of strong and effective clinical trial frameworks for the development of cancer treatments. The criteria for clinical research in India and the US are compared in this study, with particular attention paid to trial registration procedures, ethical review systems, regulatory bodies, approval processes, and safety reporting deadlines. The Food and Drug Administration (FDA) in the United States has a highly organized regulatory system, whereas the Central Drugs Standard Control Organization (CDSCO) in India is progressively bringing its regulatory framework into line with international norms. Both systems prioritize patient safety, data integrity, and scientific rigor notwithstanding their variances. Additionally, the article describes developments in cancer treatments, such as immunotherapy, targeted therapy, and personalized medicine. Additionally, it emphasizes how artificial intelligence is increasingly helping to overcome obstacles including delayed recruiting and a lack of patient diversity, which will ultimately improve trial accuracy, speed, and accessibility worldwide.

Keywords: .