Author(s): Vishal Vennu, Prem Saini

Email(s): vishal_vennu@outlook.com , prem_hsaini@yahoo.co.in

DOI: 10.5958/0974-360X.2020.00985.3   

Address: Vishal Vennu*, Prem Saini
School of Pharmacy, Lingaya’s Vidyapeetham, Faridabad-121002, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 11,     Year - 2020


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


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