Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Dec 28, 2021)
Date Submitted: Nov 3, 2019
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Knowledge and Opinions of Indian Researchers Regarding India’s New Drugs and Clinical Trial Regulations:An Online Survey
ABSTRACT
Background:
Although a few studies examined possible problems regarding the previous clinical trial regulatory guideline issued in 2016, no study investigated the awareness and opinions of researchers about the new regulatory guidelines issued in 2019.
Objective:
This study aimed to describe the Indian researchers’ knowledge and views regarding India’s new drug and clinical trial rules of 2019.
Methods:
A cross-sectional online questionnaire study was carried out by randomly selecting various Indian researchers (men and women) from multiple sources between July 2019 and September 2019. The survey questionnaires, which had already been validated, were developed using Google Forms. A web link was generated for participants to take the survey. Descriptive statistics, such as counts and percentages or means and standard deviations, were computed to describe the demographic characteristics, knowledge, and views of Indian researchers.
Results:
Out of 106 researchers, 75 researchers (70.8%), and 65 their managers, and clinical staff (61.3%) knew the new regulations. Further, 36 (63.2%), 32 (53.1%), and 31 (54.5%) researchers were agreed with the reduction in the timeline, free post-trial drug access, and welcoming equality, respectively. Further, 37 researchers (64.9%) agreed with the new changes on how to deal with severe adverse effects and compensation. Overall, 34 researchers (59.6%) accepted the new rules. Additionally, 71 researchers (67%) said that the new regulations would mostly impact on profit clinical trial studies. Generally, 91 researchers (87.5%) deemed that the new rules are highly favorable to the promotion of clinical research in India.
Conclusions:
The majority of researchers have the knowledge, agreed with the changes and deemed that the new regulations of 2019 are highly favorable to the promotion of clinical research in India.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.