When Do You Think BYOD (Bring Your Own Device) Will Become Widely Used To Capture PRO Data In Clinical Research?

A | THE BYOD APPROACH ALLOWS STUDY PARTICIPANTS to use their own wireless devices to collect patient-reported outcomes (PRO) and clinical outcomes assessments (COA) data. Regulatory bodies, such as the FDA and EMA, appreciate the advantages of this shift to BYOD, and numerous groups (e.g., CTTI and DIA ePRO Consortium) have been working to establish guidelines and processes across the industry. The key areas of focus include: ensuring scientific integrity of the assessment tool, instrument validation, defining minimum system requirements, patient compliance, instrument maintenance, and data integrity.

JOHN HUBBARD, PH.D. is a member of the board of Agile Therapeutics and former CEO of Bioclinica and has over three decades of experience, including executive-level positions with Pfizer, ICON, PAREXEL, and Hoechst Marion Roussel Pharmaceuticals.