Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders. Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed. Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation. Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.

Purpose: Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it. Materials and Methods: This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed. Results: A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance. Conclusion: It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others.

Comparison of self-medication practices with analgesics among undergraduate medical and paramedical students of a tertiary care teaching institute in Central India - A questionnaire-based study.

CONTEXT: Inappropriate self-medication can increase chances of adverse drug reactions, disease aggravation, or drug interactions. Analgesics are most commonly used as self-medication. AIMS: The aim of this study was to evaluate and compare analgesic self-medication practices among medical and paramedical undergraduate students of a tertiary care teaching institute in Central India. MATERIALS AND METHODS: A cross-sectional, observational study was conducted in 216 undergraduate medical (MBBS and BDS) and paramedical (occupational therapy/physiotherapy and BSc nursing) students. A predesigned, self-developed, semi-structured questionnaire was used. STATISTICAL ANALYSIS: The Chi-square test was used for testing statistical significance. RESULTS: The overall prevalence of self-medication with analgesics was 83.33%. Self-medication was significantly high among medical students as compared to paramedical students (P = 0.003). Significantly more medical students were aware about adverse drug reactions of analgesics as compared to paramedical students (P = 0.019). The most common source of information about drugs was previous prescription (58.33%), followed by media including the Internet (53.70%). The most dominant symptom compelling self-medication was found to be muscular pain (42.12%), followed by headache (36.57%). 54.16% of the students revealed that self-medication provides quick relief from pain. The most commonly used analgesic was paracetamol (82.40%), followed by diclofenac (22.68%). A significant number of paramedical students do not know exactly what precautions should be taken while taking analgesics (P = 0.002). CONCLUSIONS: Medical students are more indulged in self-medication practices with analgesics. Paramedical students need to be educated regarding safe use of analgesics.