Advancing Decentralized Clinical Trials Through A Unified Approach To eCOA And Digital Health Technologies

Drug developers are increasingly harnessing the combined power of objective data measured using digital health technologies (DHTs) and subjective clinical outcome assessments that include patient-reported outcomes (PROs). Uniting these two complementary mechanisms is enabling the development of comprehensive patient profiles that better inform how patients experience their disease and respond to treatment.

Combining these independent data streams significantly boosts the value demonstration of new drugs. Given the pervasive rise of drug development costs and increased time to market, bolstering value demonstration for marketed products is critical for attaining sustainable drug development and market access. In an environment where patient centricity and value demonstration are becoming a greater focus for stakeholders across the healthcare spectrum, the need to understand the 360 degree view of the patient, together with improvements in measuring patient outcomes, is critical to success.

Early planning for value evidence generation, including real-world effectiveness and differentiation in the marketplace, provides a unique opportunity for new and innovative treatments to achieve market access and to deliver greater patient accessibility to medicines. The goal of this paper is to provide a summary of the independent rise of DHTs and patient reported outcome data in clinical research, followed by a brief discussion of the combined benefits of pairing these two data streams to drive superior value demonstration.