[2] For example, while a study that tests the effectiveness of a new blood pressure cuff for a period of 10 minutes might seem innocuous, the potential exists for the patient's skin to be irritated by the device.
Both the skin irritation and the death are unexpected events, and should alert the researcher to the potential existence of a problem with the device (for instance, it could have malfunctioned and shocked the patient).
The researcher would report these AEs to the local Institutional Review Board and to the sponsor, and await direction on whether to stop the study.
[3] The Medical Error Action Group is lobbying for legislation to improve the reporting of AEs and through quality control, minimize the needless deaths.
The type of method used to elicit AEs reported by individuals for evidence on likely adverse drug reactions (ADRs) influences the extent and nature of data.
A 2018 review conducted found that some participants in clinical drug trials were asked simple open questions (i.e. 'how are you feeling?
[4] A 2022 review on adverse events in Human challenge trials found that reporting improved over time, but remains non-standardized in ways that make comparisons difficult.