Summary and Conclusions

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.