Background: Clinical trials aim to improve health care by reducing treatment costs, enhancing quality, and advancing the discovery of safe treatments. Notably, limited knowledge among resident doctors may impact research quality.
Aims and Objectives: The study seeks to evaluate awareness and knowledge of clinical trials among undergraduate, intern, and postgraduate medical students.
Materials and Methods: It was an observational, cross-sectional study conducted on 300 medical students over 3 months after approval from the Institutional Ethics Committee (IEC). The pre-validated questionnaire containing 24 items was administered through email, WhatsApp, or in person. Data were analyzed using descriptive statistics.
Results: In the study, 96.7% of participants believe the necessity of clinical trials. Notably, 72% of undergraduates and 76% of postgraduates express willingness to participate in a clinical trial. Furthermore, 93% of participants view trials as vital for innovative therapies, and 74.3% believe that they enhance health-care services. Knowledge gaps in clinical trials were evident: 56.3% of participants knew good clinical practice guidelines, 46.7% of participants were aware of them, and only 12.3% of participants knew the IEC role. However, 66.7% of participants recognized the Drug Controller General of India (DCGI) and IEC approvals as crucial for trials, and 53.7% of participants identified DCGI as the regulatory authority. 68.3% of participants could not define a placebo-controlled trial. However, 75% of participants were aware of the consequences of informed consent form non-compliance. Most knew about post-marketing surveillance (80.33%), but awareness of healthy volunteer involvement in Phase 1 was lower (48%). In addition, 62.33% of participants knew about marketing access after Phase 3, and 60% of participants were aware of adverse effects reporting procedures.
Conclusion: The study reveals a concerning lack of awareness regarding clinical trials among undergraduate, intern, and postgraduate medical students, emphasizing the need for targeted educational interventions in medical curricula.
Key words: Clinical Trial; Ethics; Good Clinical Practice; Institutional Ethics Committee
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