Patient's perspective on Clinical Trials in Indian Population: A Historical Comparative study

Abstract: Introduction - For conducting a clinical trial successfully, patients’ perspective towards it plays an important role. The patients should have a clear understanding of the reason of their participation in a clinical trial. However, there have been multiple unfortunate incidences in the past that tarnished the image of the clinical research sector in India. Since the last decade, the scenario has changed drastically with constant regulatory updates and improvements in the assurance of patient rights and safety. Nevertheless, scientific illiteracy among a major fraction of the Indian population can cause less patient recruitment and their dropout from the trial. The study aims to find out the positive or negative changes in the perception of common Indian patient population regarding clinical trials and its safety in the last 10 years considering the major regulatory changes in the Indian clinical research sector and public awareness initiatives. Background information – India is termed as the global hub for clinical trials. Clearly, the number of participants of trial subjects are a concern when number of trials are always on the upward curve. As part of a 2013 study, Dr. Kapadia evaluated the perception and understanding of 6122 patients on clinical research in India as potential clinical trial participants. In this study, many of the respondents were found out to be unaware of the basic principles behind ethical conduct of clinical trial, role of ethics committees, and measures taken by regulatory authorities that safeguards subject’s rights, safety, and well-being. Clear lack of adequate awareness and understanding was demonstrated as the main cause behind the “guinea pig” syndrome. Methodology - A survey was conducted using validated questionnaires in chronic (long-term) patients groups, and the data collection was through digital or online mode to avoid manual errors and data entry discrepancy. The data collected was analyzed statistically corresponding to our test hypothesis, largely by univariate and bivariate and if appropriate a Chi-square test for association. Conclusion - The study helped to understand the difference in the knowledge, awareness and perception of chronic patient population on the matters of clinical research, ethical conduct of research in humans, subject rights and safety assurance, compensation laws, and trustworthiness of other stakeholders in a trial. This will also pave the way to chalk out strategies to build and enhance awareness on clinical research in Indian individuals who can be potential participants in human clinical trials.