FDA statistician offers tips for evaluating wearables for clinical trials | RAPS
WASHINGTON @ Sponsors who want to use wearable devices in clinical trials should pay special attention to issues such as ensuring the clinical trials are blinded, data integrity, and whether the devices are fit-for-purpose, according to Guangxing Ken Wang, a statistician at the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health. He also emphasized that sponsors should consider verifying and validating the devices, and prespecifying their trial endpoints.