Comparison of Academic Performance of 2nd MBBS Students Participating in Quiz Versus Nonparticipators: A Retrospective Analysis

Introduction: Pharmacology quiz participants undergo training by their teachers on pharmacology which is much more rigorousthen routine pharmacology teaching program. Effect of this training for pharmacology quiz on the performance of students inthe 2nd year MBBS exams, i.e., terminal, preliminary, and university exam has not been evaluated.Methodology: Study was a retrospective analysis of scores of three exams (1st term, 2nd term, and prelim) conducted in2nd-year MBBS student in the department of pharmacology of four batches. Participators were students who had given theirnames for participation in the quiz and had undergone pre-quiz training and selected candidates were among the participatorswho got selected to take part in the final quiz. Participators were trained for the quiz. Rest of the students were considered asnonparticipators. Equal number of topper nonparticipators was chosen based on number of selected students. Marks betweenthe groups were compared with paired and unpaired t-test, Mann–Whitney U-test, and Wilcoxon Signed-rank test. P < 0.05was considered statistically significant.Results: Out of a total of 728 students, 147 were participators, 131 participated but not selected, and 16 got selected, 581 werenonparticipators, 16 toppers were selected. The theory, practical and combined marks of participators and selected students werehigher than nonparticipators and not selected students, respectively. Practical and combine marks of topper nonparticipatorswere higher than the selected students at baseline, but in 3rd term the difference was not significant (P > 0.05).Conclusion: Quiz-based teaching in pharmacology enhances performance in pharmacology

Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis

The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies—both sponsored and investigator initiated—were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study’s progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator’s (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court’s orders and a Parliamentary Standing Committee’s report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee’s (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants’ safety and well-being.

Evaluation of Ampicillin and Ceftriaxone on Ethanol Consumption as Compared to Naltrexone in Alcohol Dependant Rats.

Context: Extracellular glutamate level in reward centre of brain increases during ethanol drinking sessions. Hence, it can be hypothesized that drugs which decrease extracellular glutamate might have deaddictive properties. It has been shown that β-lactam antibiotics are potent stimulators of glutamate transporter 1(GLT1) expression. Previous studies have shown that ceftriaxone decreases ethanol consumption but this has not been compared to standard line of treatment (naltrexone). Also, no study was conducted for testing ampicillin even if in an in-vitro experiment ampicillin has shown to increase GLT1 levels more than ceftriaxone. Hence, our study’s objectives were to compare efficacy of ceftriaxone and ampicillin with naltrexone on ethanol consumption in rats. Methods: Permission of ethics committee was taken. Study was divided into two parts. Part I included standardization of model & Part II included 8 groups of six rats each. Group 1: vehicle control, Group 2: 1mg/kg/d naltrexone, Group 3: 100mg/kg/d ceftriaxone, Group 4: 200mg/kg/d ceftriaxone, Group 5: 100mg/kg/d ampicillin, Group 6: 200mg/kg/d ampicillin were given i.p injections for 15 days and Group 7: 200mg/kg ceftriaxone & Group 8: 200mg/kg ampicillin i.p. single dose. Parameters measured were ethanol & water intake per day for 15 days. Results: Groups 2 to 8 showed statistically significant decrease in ethanol intake as compared to vehicle control. Also, group 3 & 4 showed an increase in water consumption as compared to Group 1. Conclusions: Our study recommends that drugs acting on glutamate pathways like ceftriaxone and ampicillin can be explored for treatment of alcohol dependence.

Continuing oversight through site monitoring: experiences of an institutional ethics committee in an Indian tertiary-care hospital.

WHO-TDR and the Indian Council of Medical Research recommend site visits by institutional ethics committees (IECs) for continued oversight, to ensure the ethical conduct of research. Our IEC conducted seven site visits in 2008-2009 using a standardised format to monitor adherence to protocol and the informed consent process.