“We are making critical clinical trial decisions on measures that we know are bad”

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FDA
digital health
biomarkers
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2023-08-17

Christine Cong Guo of ActiGraph hit the nail on the head in a discussion with STAT’s Mario Aguilar:

In my mind, we are making critical clinical trial decisions on measures that we know are bad. It just shouldn’t be the state of the art for our industry. You know, we are continuing to rely on these measures that have been developed more than 50 years ago as the gold standard today. If it happened in any other industry, it would sound like a joke. So I think the wearable and digital measures, the fact that it is measuring patients directly in their home environment about something they’re doing in their everyday environment, this is completely aligned with what FDA wants you to do — to measure a patient’s function in their daily activity, in their daily life.

This post originally appeared on LinkedIn.