Patient-Reported Outcomes: Engaging Patients As Partners For Better Pharmacovigilance Practices

Clinical Leader
January, 2016
Author: Supriya Desai, Sciformix Corporation

Today, there is greater awareness surrounding the benefit and risk of pharmaceutical products, amongst health care professionals (HCPs) and consumers alike. Safety and efficacy data from clinical trials are no longer sufficient and there is a demand for more evidence including effectiveness of treatments as well as comparative effectiveness, relative to other therapies. This requires real world data based on longer follow-up, which is closer to and more representative of the patient population than what is typically obtained via clinical trials. Patient reported outcomes (PROs) can help fulfill this need.

PROs are data elements directly reported by patients or their surrogates about experiences with care, including symptoms, functional status or quality of life. They have gained increasing importance in healthcare and are commonly evaluated in clinical trials for drug and medical device development (1). Studies have shown that patient reports are more valuable compared to HCP reports as patients often report earlier, perceive the impact and severity of reactions differently and give more detailed descriptions. Companies, who successfully incorporate PROs in their safety and pharmacovigilance (PV) operations would likely gain a competitive advantage through direct patient involvement and higher quality of data.

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