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Background: Academic trials are essential in investigating health research questions relevant to the society. Only a few leading research institutions in India have been engaged in academic trials. Thus, there is a need to understand what factors dampen the spirit of the academician in conducting academic clinical trials. Aims and Objectives: The aim of the study is to evaluate the investigator's perception of obstacles to carrying out academic trials and to identify factors that will motivate investigators in conducting academic trials Materials and Methods: We conducted a prospective observational study in a tertiary care hospital for 6 months. Faculty members working in academic institutes were selected. A structured questionnaire was designed for the study and administered using google forms. Responses were taken on a Likert scale. Validity and reliability assessments were carried out. Mann-Whitney test was applied to assess differences between demographic groups. P <0.05 was considered significant. Results: Most of the participants rated applying for research grants (76%), obtaining funding for the study and making arrangements for compensation for trial-related events (75%) as extremely challenging. We found that the degree of challenge is significantly lower in the faculty members who conducted clinical trials in the past as against those who did not (P = 0.00069). We also found that the degree of challenge is significantly higher in the faculty members with <10 years of experience than those with >10 years of experience (P = 0.00001). Conclusion: Thus, to conclude the challenges faced by investigators were at multiple levels, most common being applying for research grants and making arrangements for the funds for payment towards participation or study-related injury. Faculty members with exposure to conducting clinical trials and with experience of more than 10 years had perceived a reduced degree of challenges. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the impact of educational intervention on knowledge, attitude, and practice (KAP) regarding pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among nursing officers. Materials and Methods: A pre- and post-single-arm interventional study was conducted at All India Institute of Medical Sciences (AIIMS), Nagpur from May 2021 to October 2021 among 48 nursing officers. Data related to KAP were obtained through validated questionnaires before and after 3 months of educational intervention. Results: The mean knowledge score among nursing officers significantly improved from 11.05 ± 3.09 to 16.77 ± 2.07 after training session ( P < 0.001). The mean score regarding attitude was significantly upgraded from 21.16 ± 5.6 to 23.79 ± 2.97 ( P < 0.001). At baseline, the mean practice score was poor (2.41 ± 2.89), which was improved after training session, but the difference is not significant. Conclusion: Educational intervention had a significant impact on knowledge and attitude toward ADR reporting. The practice of detecting and reporting an ADR to the treating consultant is improved, but it is not transformed into reporting an ADR to the PV center to a significant extent. Hence, it is recommended to streamline ADR reporting process by implementing such training modules more frequently. [ABSTRACT FROM AUTHOR]