Rev Recent Clin Trials. 2022 Oct 19. doi: 10.2174/1574887118666221019100542. Online ahead of print.
BACKGROUND: There has been a concern in the quality of clinical trials conducted in terms of data integrity, accuracy or ethical conduct. This study aimed to assess the tangible gap existing in knowledge and application of rules and guidelines among Researcher, Research staff (RS) and Eth-ics Committee (EC) members – the three research stakeholders at the study sites.
METHOD: A validated e-questionnaire with details for demography, role, years of experience, affilia-tion and questions on knowledge and understanding about their clinical research functions based on the New Drugs and Clinical Trials (NDCT) Rules 2019, including: ‘Role and responsibility, Regula-tions, Reporting timelines, Documentation, Conflict of interest and Miscellaneous’ was circulated among the seven research sites of one organization with their fourteen Institutional ECs as part of the planned annual survey. Responses with >60% correct answers were arbitrarily considered to rep-resent adequate knowledge Results Of 201participants, there were 27.4% Researchers, 50.2% were from the EC and 22.4% RS. A greater proportion of Researchers had >5 years (43.6%) of experience. The mean ±SD of correct an-swers obtained was 66.9±14.77 and was statistically significant (p<0.05) among the groups, highest for EC members (71.4±11.51), those with 2-5 years of experience (68.4±14.40), and least for the RS (56.8±11.93). Researchers (> 90%) were aware of their role in the clinical trial agreement and importance of the trial registration in Clinical Trials Registry-India. There were gaps in the Informed Consent (IC) process and post-trial access. Awareness regarding the IC process was adequate among the RS (84%). Awareness that the re-sponsibility of all delegation at site finally lies with the Researchers was adequate (60%) but 20% wrongly believed that the sponsor can have access to subject identification details. Deficiencies were noted regarding documentation, NDCT rules -2019 and serious adverse event (SAE) reporting process. Five percent answered that Data Clarification Forms were generated after reviewing the case report forms. The awareness that NDCT rules-2019 was not for medical devices, student pro-jects or Investigator Initiated Studies was inadequate (56%). The EC members’ awareness in roles and responsibilities was adequate (≥ 90%). Knowledge gaps were noted in EC monitoring of the ongoing trials (32%), and SAE reporting on SUGAM portal (8.8%), where stakeholders can access the regulator’s web services using a single window interface for clinical trial related activities. Conclusion There are gaps in the knowledge of the 3 stakeholders at site. Identifying and rectifying the gray areas will have the site better placed in performance. There is a need for regular training and assess-ments.