To establish the safety profile of a new intervention
It is extremely important for researchers to recognise AE / SAEs in clinical research that involves the testing of new drugs, technologies or interventions. Any medical occurrences in such contexts have to be investigated thoroughly to determine whether they could have resulted from the use of the novel intervention.
This is so that the safety evidence of any new interventions can be established as fully as possible before they are considered for widespread clinical use by regulatory authorities.
In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) is responsible for reviewing the safety evidence from all drug trials and for registering new drugs / medicinal products, while the Medical Device Authority (MDA) does the same for medical devices.
To add to the safety profile of an established intervention
Likewise, it is equally important to recognise AE / SAEs in research using established interventions, especially when they are tested for unlicensed (off-label) uses.
If an established intervention is found to have caused an AE / SAE which was not previously known, the AE / SAE should be reported to the regulatory authorities so that it can be recorded as a new side effect / caution / contraindication.