Clinical Data Capture: Enhancing Conventional Methods With Continuous Digital Measures

Clinical data drives drug development research and is arguably a clinical trial sponsor’s most valuable asset. The ongoing digital transformation of the clinical research industry has ushered in a wide variety of wearables, biosensors, and similar data capture technologies that allow sponsors to collect existing endpoints with more accuracy and to capture novel endpoints that were not previously measurable. These technologies may also make trials more efficient and less burdensome to participants while providing a more meaningful and complete understanding of patients’ conditions and responses.¹ Despite these advances, most clinical trial sponsors continue to rely heavily on conventional data capture methods like patient questionnaires and clinic-based functional assessments to quantify motion-based outcomes throughout a study.

These traditional methods are deeply embedded within the clinical research paradigm, yet sponsors have an incredible opportunity to increase the precision, quality, and completeness of their data. Augmenting subjective patient reports and point-in-time clinical outcome data with continuous digital measures provides better visibility into participant behaviors and the contexts within which they occur. In this eBook, we discuss several conventional data capture methodologies and ways in which objective, real-world actigraphy data can enhance or, in some cases, even replace these traditional assessments.