The Paper Chase: Clinical Outcomes Assessments In The Digital Age

By Mark Wade, Global Practice Leader Life Sciences, COA SME, TransPerfect

Patients are, at last, gaining a voice in healthcare. Stakeholders have come to recognize that patients have valuable information to share about their experiences with diseases and medications that should influence policy and treatment decisions.

The U.S. Food & Drug Administration (FDA), for example, has launched an initiative, “The Voice of the Patient,” to gather patient perspectives across specific disease areas. Information reported by clinical trial participants on their symptoms and health practices is increasingly important to the success of studies proving the safety and efficacy of investigational drugs. Then, once products are on the market and payers require evidence of their health economic value, there’s a growing demand for patient-reported data as proof points.

Patient data are collected via clinical outcomes assessment (COA) tools that can be either paper-based or electronic, with the latter in the form of voice response systems, web portals, specialized handheld devices, and smartphones. Here, we’ll review the pros and cons of the different modalities and offer our perspective on the future of COA tools.