Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance
Suvekshya Aryal,
Jennifer M. Blankenship,
Shelby L. Bachman
et al.
Abstract:Digital health technologies (DHTs) have the potential to modernize drug development and clinical trial operations by remotely, passively, and continuously collecting ecologically valid evidence that is meaningful to patients’ lived experiences. Such evidence holds potential for all drug development stakeholders, including regulatory agencies, as it will help create a stronger evidentiary link between approval of new therapeutics and the ultimate aim of improving patient lives. However, only a very small number… Show more
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