ISBN 978-93-91882-02-0 (Print)
ISBN 978-93-91882-11-2 (eBook)
DOI: 10.9734/bpi/mono/978-93-91882-02-0

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.

 

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Contents


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

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 1
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH0

Background/purpose: Few studies have detailed the awareness and opinions of investigators and the ethics member about the past rules. However, no study studies the perception and perspectives of Indian researchers about the latest drugs and clinical trial rules 2019 (NDCTR-19). The purpose of the current research is to address this limitation.

Methods: A web-based online survey was developed using a widely accepted Google form with an already validated questionnaire based on the Checklist for Reporting Results of Internet E-Surveys. A web link was created for participants to perceive the survey. The data was collected by sending the link to various researchers across India between July 2019 and September 2019. The perception and perspectives of Indian researchers were described in the count (%) and means (standard deviations). Results: Of 106 researchers, 75 (70.8%) had a perception of the NDCTR-19, including from all zones (100%, p <.0001). The modification in the timeline, open post-trial drug passage, and welcoming equality were accepted by 36 (63.2%), 32 (53.1%), and 31 (54.5%), respectively. The recent advances in severe adverse effects and compensation were accepted by 37 (64.9%). Also, most reported that sharing the NDCTR-19 with other researchers, especially from the central zone, said that the NDCTR-19 would change the working environment (100%, p <.0001, respectively). Conclusion: The results indicate that the NDCTR-19 can facilitate speed-up trials and extend India's pharma industry. The findings will be of interest to the investigators and pharmaceutical companies' stakeholders at national and international levels.

The Drugs and Clinical Trial Rules: An Overview

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 2-4
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH1

Globally, most nations follow the regulations to closely supervise clinical trials to evaluate their data integrity, protect patients' safety, and assess sites and sponsors' adequacy. The chapter provides an overview of these clinical trial regulations. The chapter also highlights the clinical trial regulations that began and developed to control medical therapies due to unethical human experiments. In addition, the chapter outlines India's drug and clinical trial regulatory systems development over the past decades, the new changes, and it is important to know these changes by researchers.

The Procedure of a Web-based Online Survey Study

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 5-8
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH2

A Web-based online study, an open survey for various Indian researchers was conducted to investigate the Indian researchers’ awareness and opinions on the new drugs and clinical trial rule 2019 between July and October 2019. These researchers were selected randomly using multiple sources across India. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey.

Clinical Trials: Global and Indian Context

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 9-18
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH3

The concept of the clinical trial is ancient in the world, including India and the long history of clinical trials spans a wide variety of scientific, ethical, and regulatory challenges. Researchers require the most promising results from pre-clinical animal experiments to begin clinical trials on humans after the approval of the regulatory authority and ethics committee. Trials on humans are classified according to their purpose into type and phases to determine whether the new drug is safe and effective for successful treatments. The process of new drugs through phases I to IV typically takes a decade or longer and often costs well over a billion dollars. Of all drugs tested in human clinical trials, only 10% are ultimately approved by a national regulatory authority and marketed.

Unethical Human Experimentation in India

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 19-23
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH4

Globally, India is an emerging hub for clinical trials with having a growth of 30 percent per year. The average cost of a clinical trial in India is considerably lower than in the United States. However, incomplete and biased unethical trials on human beings have been conducted around the world, particularly in India. Some unethical experiments have been conducted recently; some are still being conducted. The most common issues and challenges regarding unethical human experimentation in India have been described in this chapter.

India's Clinical Trial Regulations: History, Recent Changes, Knowledge and Impact

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 24-29
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH5

A robust regulatory system in compliance with global regulatory guidelines has been developed over the past decade to attract global stockholders and expand clinical research in India. The Indian history of drug regulation, in particular, goes back to the British colonial era. In 1940, the Drugs and Cosmetic Acts become the Drugs and Cosmetics Rules of 1945 in India. India’s government has developed various ethical and regulatory guidelines over a period under these rules through a regulatory agency known as the Indian Council of Medical Research. Details of these modifications have been described previously. This chapter outlines the history of India's clinical trial regulations, recent changes, knowledge of Indian researchers, and the impact of India's new drugs and clinical trial rules of 2019.

Conduct Clinical Trials during the COVID-19 Pandemic in India

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 30-32
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH6

The major pandemics have been noted in the historical record and now Coronavirus Disease-2019 (COVID-19). The pathogen was first identified in late December 2019 in Wuhan, China, and the first case of COVID-19 was reported on 30 January 2020 in Kerala, India. At present, India has the second-highest number of confirmed cases in the world after the United States. In this situation, the COVID-19 pandemic crisis has impacted clinical research worldwide, especially in India. The chapter summarizes the conduct of clinical trials during the COVID-19 pandemic in India.

Development of an Online Survey from Multiple Sources across India

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 33-37
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH7

To date, no study has conducted online surveys using free online Google Forms. Thus, this chapter addresses this limitation by describing the strengths and weaknesses of developing an online survey from multiple sources across India using freely available Google Forms. It also provides an understanding of how this methodology could be utilized in different settings to investigate various research.

The Knowledge and Views of Indian Researchers

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 38-46
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH8

No study studied the knowledge and views of Indian researchers about changes in the new drugs and clinical trial rules (NDCTR-19). The present study aimed to address this gap. In this cross-sectional web-based online survey, a total of 106 male and female researchers were chosen randomly from various sources across India over three months, starting from July 2019. The study results suggest that most researchers know and agree with the modifications. NDCTR-19 forces to extend clinical research and the pharmaceutical industry in India. Overall, this study strengthens the aim of the NDCTR-19 that promotes clinical trials, accepts new drugs, and enhances the country's standards ethical norms.

The Perception and Perspectives of Researchers by Indian Zones

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 47-53
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH9

No research evaluated the perception and perspectives of researchers from different Indian zones on India's new drugs and clinical trial rules of 2019 (NDCTR-19). The current study aimed to approach this passage. The results advance the goal of the new rules that help speed up trials and extend the pharma industry in the country. An extensive study at the national level, including all six zones, is needed to generalize researchers' beliefs on the topic.

The Difference in Views of Various Researchers

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 54-58
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH10

About the new drugs and clinical trial rules of 2019 (NDCTR-19), no study surveyed the differences in views of various researchers, such as investigators, co-investigators, members of the ethics committee (EC), research assistants, coordinators, associates, and managers. The current study aimed to address this gap. The results of this study indicate that there is a significant variation in the views of different researchers about the changes of NDCTR-19. Future study is required on the larger sample at a national level to generalize the views of various researchers on the topic.

Summary and Conclusions

Vishal Vennu

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 30 August 2021, Page 59-62
https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH11

Few studies have detailed the awareness and opinions of investigators and the ethics member about the past rules. However, no study studies the perception and perspectives of Indian researchers about the New Drugs and Clinical Trial Rules of 2019 (NDCTR-19). A web-based online survey was developed using a widely accepted Google form with an already validated questionnaire based on the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) to address this limitation. A web link was created for participants to perceive the survey. The data was collected by sending the link to various researchers across India over three months, starting from July 2019. The perception and perspectives of Indian researchers were described in the count (%) and means (standard deviations). Of 106 researchers, 75 (70.8%) had a perception of the NDCTR-19, including from all zones (100%, p <.0001). The modification in the timeline, open post-trial drug passage, and welcoming equality were accepted by 36 (63.2%), 32 (53.1%), and 31 (54.5%), respectively. The recent advances in severe adverse effects and compensation were accepted by 37 (64.9%). Also, most reported that sharing the NDCTR-19 with other researchers, especially from the central zone, said that the NDCTR-19 would change the working environment (100%, p <.0001, respectively). The results indicate that the NDCTR-19 can facilitate speed-up trials and extend India's pharma industry. The findings will be of interest to the investigators and pharmaceutical companies' stakeholders at national and international levels.