Opportunities and challenges of AI-driven clinical trial design and management in improving patient recruitment for clinical trials in India: An evaluation based on stakeholder perspectives. Clinical trial is an integral part of the scientific world and advancement of which drives the progression of the entire healthcare system. However, there have been serious issues identified within the sector, which are slowing down the advancement of the sector, and the most prominent being poor patient recruitment. The present study identified the reason for this inefficiency and has determined methods to enhance recruitment by leveraging the power of artificial intelligence. Recruitment issues were mostly related to complexity of trial design along with patient compliance and site staff related issues. AI driven methods to optimize the trial design like predictive analysis, were determined thereby improving the recruitment. Moreover, AI assisted wearables for remote monitoring devices helped to reduce unnecessary site visits thereby improving patient compliance and retention. AI assistance for patient identification and data collection is estimated to reduce manual errors and site staff burden and hence improving the overall efficiency of the clinical trial. Amidst all the positive aspects of the AI integration there are numerous issues associated with the AI integration, starting from technical issues like lack of standardized data sets, potential bias in the outcome, lack of expertise to ethical concerns like uncertainties in data privacy measures, which stands out to be most concerning one. Efficient and ethically sound adaptation of AI requires measures from multiple facets, including the formulation of structured regulations and core committee within regulatory body dedicated to overseeing the use of AI in clinical trials and training programmes to educate trial staff at all levels. Artificial Intelligence is a concept which will continue to expand and spread across various sectors in the coming years and this expansion will be inevitable in the health sector as well. However, unlike any other sector the health sector especially clinical trials, is very sensitive and anything that is done in regard to this sector must always be evidence-based and by considering the safety and rights of the patients. AI’s transformative power to advance the clinical trial sector is evident from this research, however there several issues that need to be addressed to make sure the integration is done in compliance with all the regulations and without compromising the comfort and choices of the patients, which is of paramount importance.