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Background: Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria. Materials and Methods: Data were retrieved after the Ethics Committee's approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as "BEFORE" data, while the remaining data were categorized as "AFTER." Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann-Whitney tests were used to compare the "BEFORE" and "AFTER" groups. Results: A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants (23.59%) with approximately 48% of these being vascular. The "AFTER" group noticed a decrease in the total number and length of SAE subcommittee meetings. In the "AFTER" group, there was a significantly higher median number of agenda items/meetings (8 [4.5-10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1-5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the "AFTER" group, there were no discrepancies in reporting SAE. Conclusion: There is acceptable adherence to SAE reporting criteria.
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Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann-Whitney U-test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed , more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion: The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.
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CONTEXT: The elderly in India form a heterogeneous subset of the population with significant disease burden variations. However, there are no data available regarding the type of research studies conducted in an elderly population in India. AIMS: The aim of this study was to analyze the research studies conducted in the elderly population in India based on data from the Clinical Trials Registry of India (CTRI). SETTINGS AND DESIGN: This was an "audit" of available data on the CTRI website. PARTICIPANTS AND METHODS: Following exemption from the Institutional Ethics Committee, all studies in the elderly population registered in CTRI from its inception (July 2007 to August 2019) were reviewed. Data captured with respect to geographical distribution, study designs used, therapy area, trial registration, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 21,400 studies in CTRI, a total of 99 (0.46%) studies involved only elderly patients. Of these studies, 60 (60.6%) were interventional, whereas 39 (39.4%) were observational. Of all the interventional studies, 17 (28%) tested drugs, 26 (43%) tested a lifestyle intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and physiotherapy. Postgraduate theses constituted 60 (60.6%) studies. Eighty-seven (87.9%) were academic projects, eight (8.1%) were government-funded studies, and only four (4%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was the central nervous system, followed by community medicine and orthopedics. CONCLUSIONS: This study depicts the underrepresentation of the geriatric population in clinical studies.
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OBJECTIVE: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. MATERIALS AND METHODS: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. RESULTS: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66%) respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%). 67 (49.62%) respondents have accessed. 67 (49.62%) did not have the time to visit intranet site whereas 67 (49.62%) have not accessed intranet. 89 (65.92%) respondents were not aware of the drug spectrum. 101 (74.81%) respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33%) knew about the intranet periodical drug spectrum, but most of the respondents (33.33%) explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. CONCLUSION: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but the participants had a lot of suggestions. Thus, intranet has immense utility, and to make drug spectrum more readable suggestions of the respondents needs to be incorporated which in turn can benefit the medical fraternity as a whole.