RESUMEN
Background: Clinical trials (CTs) play a significant role in timely enhancement of health-care quality. It aids us to find an effective and safe treatment. Clinical research is rapidly developing in India and more graduates from medical, paramedical, and other scientific fields are enrolling for clinical research training. Aims and Objectives: The aims of this study were to know the knowledge and awareness of CT among undergraduate medical students. Materials and Methods: This was a cross-sectional and questionnaire-based study conducted among medical students at a tertiary care hospital in South India from January to February 2022. These questions were designed for assessing knowledge and awareness about CT. After validation, students were administered the questionnaire through the Google form. The data were recorded and analyzed using Microsoft Excel (2019 version) and the results are explained in frequency and percentage. Results: A total of 296 students were sent Google form-based questionnaire, out of which 278 responded with completely filled up questionnaire, giving a response rate of 94%. About 82% reported correctly that healthy normal human volunteers participate in phase 1 of CT. Majority of the students (95%) were aware what is informed consent. Only 98 (35%) students were aware that the request for authorization to conduct CT is given in form 44 as per drugs and cosmetics act. Around 43.16% responded correctly about the time period taken for completion of CT, majority of the students (90%) knew who is responsible for conduction of CT. One hundred and seventy (61.15%) reported correctly that adverse drug effects and new indication or use of the drug is studied in phase 4 and majority were aware that phase 4 is also known as post marketing surveillance. In the study, 204 (73.4%) students were aware that innovatory company of a new drug has to take approval from Institutional Review Board or Institutional Ethics Committee before phase 0 of clinical trial. Majority 240 (86.33%) of the students were aware what is pharmacovigilance. The last question in our study was to assess student’s interest in taking up clinical research in future, only 41% of students showed interest in choosing clinical research as a career option. Conclusion: In the present study, undergraduate medical students’ knowledge regarding clinical trial was average and limited number of students expressed their interest in conduct of CT. A scientifically conducted research helps in evidence-based medicine, which, in turn, improves the patient care and promotes health. A great number of medical students may pursue research in future; hence, it is crucial for medical students to be knowledgeable about clinical research. Therefore, formal, educative, and regular training of medical students is required for choosing clinical research as a career option and conduct high-quality research.
RESUMEN
Background: Pharmacovigilance has constantly gained importance in the past 15 years, relating to absolute amount of adverse drug reactions (ADRs) and to the fact that several hospital admissions are due to ADRs. Knowledge of ADRs and practice of pharmacovigilance by healthcare professionals will definitely help to evaluate the quality of pharmacotherapy in hospitals and effectively decrease the occurrence of ADRs. Aims and Objectives: The objectives are as follows: (1) To assess the knowledge, attitude, and practice of health care professionals (HCPs) toward ADR monitoring and (2) to assess the causation of underreporting of ADRs. Materials and Methods: This study was a cross-sectional questionnaire-based study. The questionnaire was distributed to 328 HCPs which included al doctors, nurses and pharmacists serving in ESIC Medical College and Hospital, Kalaburagi. HCPs who did not give consent to fill the questionnaire were excluded from the study. Results: The response rate was 82.92%. In our study, only 25.75% were aware that ADR reporting is to be done by doctors, nurses and pharmacists, and 40.44% felt that ADR reporting should primarily done by doctors alone. Overall participants who knowledge about ADRs and pharmacovigilance were 48.8%. Although 75.7% participants agreed that ADR reporting is important, over 76.5% HCPs felt that reporting ADR would be an obligation. In this study 12.5% HCPs have ever reported ADR despite having experienced one during their clinical practice. Majority of the HCPs had a belief that a single ADR reporting would not change the ADR database; hence, this could be one of the reasons for low rate of reporting ADRs. Conclusion: In our study, though the level of knowledge and attitude toward ADR reporting was adequate among the HCPs, there was poor practice of ADR reporting. Necessary measures to be taken to create awareness among HCPs about Pharmacovigilance Programme in India. They should be trained to spontaneously report ADRs.