Curricular adequacy on basics of clinical trials

Abstract

INTRODUCTION: Clinical trials are integral to innovation in the treatment modalities and are conducted to assess the safety and efficacy of novel drugs. Clinical trials of modern era have evolved through stern consequences and tragedies in the past. This study was designed to know knowledge on ethics, adverse drug reactions (ADRs), and tragedies in clinical trials among interns and postgraduates (PGs). METHODOLOGY: A cross-sectional study was carried out on graduates undergoing internship (interns) and PG residents of a medical college and a dental college from Punjab. This descriptive cross-sectional study was conducted on 151 professionals of medical college and 100 professionals of dental colleges in Punjab with the help of a prevalidated questionnaire. The data were then analyzed using descriptive statistics. RESULTS: There was no significant difference between dental and medical doctors regarding ethics and ADRs, but a significant difference was observed among interns and PG residents, with interns having higher awareness regarding ethics and ADRs. There was no significant difference ( P = 0.941) in knowledge among dental and medical doctors as well as among interns and PG residents, with P = 0.264 about tragedies in clinical trials. CONCLUSION: From the study, it can be concluded that interns and PGs do not get enough exposure to basics in clinic research such as research ethics, ADRs, and tragedies in clinical trials. It is suggested that there is a requirement for suitable modifications in the teaching curriculum at undergraduate level and regular training must be provided to professionals.

Clinical Trials Registry – India: A decadal perspective

“…[ 20 ] PG theses often report findings which are incomplete, inadequate and lack uniformity. [ 21 ] Like other researchers,[ 22 ] we have also observed that students do not have clear concepts regarding clinical trials. Outcome is often confused with results and interventional trials are labelled as observational along with mislabelling of trial phase.…”