Real-World Data: US FDA Gets 2 Out Of 10 In Abernethy’s Self-Assessment Of COVID Usage

03 Sep 2020

But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.

Stylized measuring ruler watercolour illustration. One single object, front view, green color, cute design, 10 centimetres long. Hand painted colorful sketchy drawing, isolated clip art element. — Amy Abernethy was asked to rate the role of real-world data in combatting COVID on a scale of 1-10. • Source: Shutterstock

The COVID-19 pandemic has highlighted the importance of having real-world datasets that are fit for purpose and that regulators know how to use, Amy Abernethy, principal deputy commissioner of the US Food and Drug Administration, said on 2 September.

In a prerecorded fireside chat and live question-and-answer session at the Healthcare Analytics Summit, Abernethy said the COVID crisis has...