Exco InTouch predicts ever increasing uptake of mobile electronic patient reported outcomes (ePRO) due to the multiple benefits that it brings to the market.
Electronic data collection has grown rapidly over the course of the last ten years and has already emerged as a common asset in clinical research for the completion of Clinical Outcome Assessments (COA), including the outcomes captured directly from patients; patient reported outcomes (PRO). The global growth of mobile technology has provided a new and efficient method of accessing patients, creating an ideal platform for capturing ePRO assessments.
Mobile eCOA has brought a plethora of benefits to clinical studies. In addition to supporting diaries and questionnaires, native apps have proven a highly useful resource for facilitating the collection of objective data from medical devices, such as spirometers and glucometers, and wearable technology including activity trackers, alongside patient diaries. Data from these devices, transmitted directly into an app via Bluetooth®, enables the collection of physiological data without the need for the patient to complete a site visit or the requirement to transcribe results manually.
Mobile eCOA can also boost patient engagement through the use of a simple, yet familiar interface supported by motivational messages, alerts, reminders and educational materials as appropriate for each study. Additionally, alerts can be raised to sites to highlight missed entries, enabling them to contact patients and discuss any difficulties or misunderstandings before the patient is lost to follow up.
Furthermore, mobile offers a safe and secure method of collecting patient data, protecting confidentiality in ePRO through the introduction of unique PINs created by the users. Both data transmission and offline storage is secured through data encryption. Data accessibility enables real-time access to PRO data by sites and sponsor teams through reports and metrics, providing comprehensive oversight to both individual and merged data.
Electronic data collection provides the benefit of being applicable through either the BYOD (Bring Your Own Device) approach or through provisioning devices. Adoption of the BYOD approach to collect eCOA data, which has been used in late phase post approval studies for some time, is now becoming increasingly used in Phase II & III clinical trials. Moreover, the use of apps simplifies device management, for example, by enabling remote deployment of interim study updates, without any need to recall patients and their devices back to sites.
As ePRO has become more embedded as a tool for clinical data capture, many PRO instruments that are widely accepted in paper formats have been adapted into ePRO versions. Since the manual, paper-based process for collecting PROs may not only be cost- and time-inefficient, but also unreliable, mobile devices will play an ever increasing role in the accumulation of patient endpoint data due to its ease of accessibility and cost- and time- efficiency.
Tim Davis, CEO and Founder of Exco InTouch, commented: “Mobile eCOA has proved to be highly beneficial and versatile for use in clinical trials, significantly improving the efficiency of studies and the quality of patient reported outcomes. It is set for further expansion and growth as the industry escalates the adoption of existing mobile PRO as the standard approach to self-reported clinical data.”