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.