The BYOD Revolution

With the ever-present need to increase enrollment and engagement of patients, and the growing popularity of paperless trials, pharmaceutical and biotechnology companies worldwide are embracing the use of mobile devices across the entire clinical development landscape. By increasing the speed of communication and improving the reliability of data, the Bring Your Own Device (BYOD) trend has already greatly cut costs associated with clinical trials. Moving forward, BYOD has the potential to revolutionize a range of areas across clinical development, including recruitment and subject screening, patient payment, clinical assessments, data capture, and data analysis.

Of course, with anything novel comes new challenges. The Food & Drug Administration (FDA) has released several versions of its Guidance on Mobile Medical Applications and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) authored a version specific to Clinical Outcomes Assessments (COAs) and ISPOR ePRO Good Research Practices. One of these new challenges is the adaptation and localization of historically paper-based content for an electronic format.

Additionally, with an increasing number of ex-US subjects in global studies using smartphones to book doctors' appointments, set medication reminders, or check glucose levels, there is less direct site involvement and an immediate need to ensure the foreign language content is both linguistically accurate and functionally usable.

Localizing an app from one language into another will naturally affect the user interface. Mobile interfaces—in which space is at a premium—are especially sensitive to changes in text length, line breaks, button/link positioning, image placement, etc. Post-localization testing, which is conducted by a native-speaking subject-matter expert, ensures that functionality issues are caught and addressed prior to launch.

While pharmaceutical, biotechnology, and medical device companies continue to face the pressures of subject recruitment, monitoring, and levels of engagement, the BYOD movement offers some hope in changing the tide. By implementing best practices in the localization process, life sciences companies can ensure that data integrity and trial results are not compromised—which in turn will help speed the long-term adoption of electronic devices.