ABSTRACT:
There is no research scrutinized the perception and perspectives of researchers from different Indian zones on India's current clinical trial rules. This study aimed to approach this passage. A total of one hundred and six researchers were selected from the four Indian zones: northern, central, western, and southern. Data were gathered in three months from July 2019 using previously validated questionnaires placed in the google form. The descriptive statistics, such as count (percentages), and means (standard deviations) used to show the results by zones. Most researchers from four zones significantly (p <.0001) had a perception of the new rules. Also, especially from the central zone stated it beneficial to discuss the new rules with other researchers, and the new rules would change the way of working (p <.0001, respectively). Moreover, most central and western zones significantly (p <.0001) informed that the Ethics committee could face new difficulties from the new rules. Most from the western zone assume that the new reforms, such as reducing timelines, free post-trial drug access, clinical trial approval validity, and welcoming equality, are appropriate significantly (p <0.05). Overall, most western zone accepted on the new rules (100%, p = 0.044), serious adverse event reports, and compensation (100%, p = 0.028). 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.
Cite this article:
Vishal Vennu, Prem Saini. The Perception and Perspectives of Researchers from Different Zones On India's Current Clinical Trials Rules. Research J. Pharm. and Tech. 2020; 13(11):5654-5658. doi: 10.5958/0974-360X.2020.00985.3
Cite(Electronic):
Vishal Vennu, Prem Saini. The Perception and Perspectives of Researchers from Different Zones On India's Current Clinical Trials Rules. Research J. Pharm. and Tech. 2020; 13(11):5654-5658. doi: 10.5958/0974-360X.2020.00985.3 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-11-100
REFERENCES:
1. Shenoi A. Biomedical research in India: law and ethics at crossroads. Sol Chan. 42(4); 2012: 527-538.
2. Bajpai V. Rise of clinical trials industry in India: An analysis. ISRN Public Health. 2013; 2013.
3. Fernandes S.D. et al. A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. Res Social Adm Pharm. 15(1); 2019: 109-113.
4. Porter G. Regulating clinical trials in India: The economics of ethics. Dev World Bioeth. 18(4); 2018: 365-374.
5. Clinical trials in India: ethical concerns. Bull World Health Organ. 86(8); 2008: 581-582.
6. Gulhati C. Needed: closer scrutiny of clinical trials. Indian J Med Ethics. 1; 2004: 4-5.
7. Yee A. Regulation failing to keep up with India's trials boom. Lancet. 379(9814); 2012: 397-398.
8. Jesani A. and Srinivasan S. New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights. Indian J Med Ethics. 4(2); 2019: 89-91.
9. G S. and Lc P. New Drugs and Clinical Trial Rules 2019, What is New? Our Views from Ethical Perspective. J Assoc Physicians India. 67(10); 2019: 75-76.
10. Chatterjee P. India tightens regulation of clinical trials to safeguard participants. BMJ. 346; 2013: f1275.
11. Shivayogi P. Vulnerable population and methods for their safeguard. Perspect Clin Res. 4(1); 2013: 53-57.
12. Burt T. et al. Clinical research environment in India: Challenges and proposed solutions. J Clin Res Bioeth. 5(6); 2014: 1-8.
13. Kadam R. et al. Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators. Perspect Clin Res. 7(2); 2016: 81.
14. Davis S. et al. Ethics committees and the changed clinical research environment in India in 2016: A perspective! Perspect Clin Res. 8(1); 2017: 17.
15. Rake B. and Haeussler C. Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily. PLoS One. 14(1); 2019: e0210163.
16. Kondal A. et al. Clinical Trial Regulations in India: Progress and challenges arising from recent amendments to schedule Y of the Drugs and Cosmetics (D&C) Act 1940 (D&C Rules 1945). Pharmaceu Med. 30(1); 2016: 1-13.
17. Lahiry S. et al. Paradigm shift in clinical trial regulations in India. Ind J Rheum. 13(1); 2018: 51-55.
18. Eysenbach G. and Wyatt J. Using the Internet for surveys and health research. J Med Internet Res. 4(2); 2002: e13.
19. Ritter P. et al. Internet versus mailed questionnaires: a randomized comparison. J Med Internet Res. 6(3); 2004: e29.
20. Eysenbach G. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. 6(3); 2004: e34.
21. Vennu V. and Dahiya S. Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol of a Cross-Sectional Online Survey Study. JMIR Res Protoc. (forthcoming); 2019: doi:10.2196/14744.
22. Vennu V. and Saini P. Development of an Online Survey of Researchers’ Knowledge and Opinions About the New Drug and Clinical Trial Regulations From Multiple Sources Across India: SAGE Publication Ltd; 2020.
23. Nijhawan L.P. et al. Informed consent: Issues and challenges. J Adv Pharm Technol Res. 4(3); 2013: 134-140.
24. Parikh R.M. et al. Perception of various stakeholders regarding clinical drug trial industry in India. Perspect Clin Res. 2(3); 2011: 86-89.
25. Singh N. et al. New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee. Perspect Clin Res. 11(1); 2020: 37-43.
26. Urooj M. et al. Compensation to clinical trial participants in India: A gap analysis. Int J Pharm Investig. 7(2); 2017: 41-46.
27. Travis L. One of many free survey tools: Google docs. J Electr Res Med Libra. 7(2); 2010: 105-114.
28. Leece P. et al. Internet versus mailed questionnaires: a randomized comparison (2). J Med Internet Res. 6(3); 2004: e30.