Advancing Pediatric Drug Development

The quality and quantity of reports of suspected ADRs from young people

Briefly describe your research question :

Spontaneous adverse drug reaction reports to the UK regulatory agency (MHRA) have shown a difference in both the type of drugs and reactions reported, when comparing reports about young people, and those that originated from a young person themselves (Bhoombhla 2020). The reactions that were identified by young people included serious mental health issues. This difference may also be true in clinical trials - but it would require large scale review of a number of trials to look for those with reporting that included young people directly, and those that relied on their parents/caregivers reporting. These data could provide useful guidance for future clinical trials in terms of ensuring that AE/SAE reporting by young people directly (in addition to parents) is facilitated.

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Idea No. 164