India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers

This book covers the development of an online survey from multiple sources across India using a Google Form to study the perception and perspectives of Indian Researchers regarding the changes in India’s New Drugs and Clinical Trial Rules of 2019 (NDCTR-19).

Undoubtedly, it is essential to develop a web-based online survey to research this current coronavirus disease 2019 (COVID-19) pandemic outbreak situation. At the same time, it is also vital to learn the perception and perspectives of Indian researchers because they serve as communicators between sponsors, ethics committees, and patients in clinical trials. Thus, their views are necessary to decide whether the trials are being administered as per the NDCTR-19 and appropriate ethical standards. Moreover, these professionals perform an indispensable role in documenting and reporting to their investigators and the ethics panel if unfair trials are reported, notably on vulnerable peoples.

Although many studies on Indian clinical trial regulations have been accompanied, and articles published, few earlier researchers have detailed the awareness of principal investigators and the members of the ethics committee about the past clinical trial rules. However, they neglected to know the perceptions and perspectives of researchers, such as research assistants, coordinators, associates, and managers across India. These limitations in the literature have encouraged me to prepare a volume covering the methodology developed to study the knowledge of these researchers regarding the changes in NDCTR-19.

The book comprises 11 chapters. The first chapter represents an overview of the drugs and clinical trial rules. The chapter highlights these rules in the global and Indian context. The second chapter discusses the procedure of a web-based online survey study to investigate the awareness and opinions of researchers on the NDCTR-19. The third chapter outlines clinical trials in detail in the global and Indian context. The chapter summarizes clinical trial phases, design, and ethical aspects in detail. The fourth chapter evaluates the past and recent incomplete and biased unethical trials on human beings in India. The chapter also highlights the necessary step was taken by the Indian government to address specific reports of unethical clinical trials. The fifth chapter summarizes the history, recent changes, knowledge, and impact of NDCTR-19. The sixth chapter provides an introduction to COVID-19 and discusses the conduct of clinical trials during the COVID-19 pandemic in India. The seventh chapter exhibits the development of an online survey from multiple sources across India. The chapter also summarizes the strengths and weaknesses of the methodology. Chapter 8 provides the knowledge and views of Indian researchers, followed by chapter 9 provides according to Indian zones and Chapter 10 provides various views of different researchers according to their job roles. The final chapter (Chapter 11) presents the complete summary and conclusions.