Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 17, 2019
Open Peer Review Period: May 22, 2019 - Jun 5, 2019
Date Accepted: Nov 12, 2019
(closed for review but you can still tweet)
Awareness and opinions of research professionals about India's new drugs and clinical trials regulations: Protocol for a cross-sectional online survey
ABSTRACT
Background:
Although several studies have conducted and articles published on India's clinical trial regulations, very few have examined the views and thoughts of investigators and members of ethics boards about modifications to the previously published regulations. But neglected other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study yet investigated the awareness and opinions of Indian research professionals concerning the new regulations of 2019.
Objective:
The study aims to describe the awareness and opinions of professionals regarding the new drugs and clinical trials regulation.
Methods:
In this cross-sectional web-based online design, the open survey for various Indian men and women research professionals will be conducted. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already validated, were developed the form function in Google docs. A web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas numbers and percentages will be exhibited for certain variables.
Results:
This survey is opened on July 2019 and will be completed in three months. The data analysis is expected to commence in December 2019. Results will be presented through graphs (histograms or pie charts) or tables.
Conclusions:
This survey results will represent the level of awareness and opinions of professionals regarding the new regulation that will support the development of clinical research and pharmaceutical industry in India through advancing up clinical trials, approval of new drugs, and enhancing the ethical norms in the country.
Citation
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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.