The difference in views of various researchers about changes in the new drugs and clinical trial rules in India

Abstract

Some studies detailed the awareness and opinions of investigators and the members of the ethics committee about the previous rules. However, no study surveyed the differences in views of various researchers (such as investigators, co-investigators, members of the ethics committee (EC), research assistants, coordinators, associates, and managers) about the new drugs and clinical trial rules (NDCT Rules). The current study aimed to address this gap. In this online survey, a total of 106 various researchers were chosen randomly from different sources across India between July 2019 and September 2019. The various researchers classified into the following three groups based on their job role: investigators or co-investigators (n=24), members of the ethics committee (n=21), and other researchers (n=61). The difference in views of various researchers has shown in percentages. Out of 106 various researchers, most of the investigators or co-investigators significantly reported that the changes in reducing clinical trial timeline (87.5%, p <.0001) and equality are proper (87.5%, p = 0.028). However, the majority of other researchers significantly said that the severe adverse events report and compensation are adequate (78.6%, p = 0.005). Overall, the majority of members of the ethics committee significantly reported neutral about the changes in NDCT Rules (85.7%, p = 0.037). The results of this study indicate that there is a significant variation in the views of different researchers about the changes of NDCT Rules. Future study is required on the larger sample at a national level to generalize the views of various researchers on the topic.