Onsite Serious Adverse Events Reporting: A Seven Year Experience of
Institutional Ethics Committee of a tertiary care hospital.
Abstract
Aims: 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 19th March 2019. Study aimed to ascertain whether various
stakeholders were reporting in accordance with the evolving SAE
criteria. Methods: Data was retrieved after Ethics approval between
August 2014 and December 2021. Data gathered before 19th March 2019, was
categorised as “BEFORE” data while remaining data was categorised as
“AFTER”. Utilising causality, on-site SAE reporting, and the ethics
committee review procedure, we evaluated the compliance. The data was
evaluated using descriptive statistics, appropriate statistical tests
were used to compare the “BEFORE” and “AFTER” groups. Results: A
total of 163 (6.9%) of 2361 studies were drug trials. 26 clinical
trials with 77 SAE, 92.3% of which were in 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 sub-committee meetings.
In the “AFTER” group, there was 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 [IQR: 1-5 days]. In non-death SAEs, there
was no significant difference in the compensation paid. Conclusion:
There is acceptable adherence to SAE reporting criteria.