Decision-Making For The Adoption Of A Bring Your Own Device Strategy

By Estelle Haenel, Kayentis Chief Medical Officer

Electronic devices have been systematically provided to participants to report Patient Reported Outcome (PRO) data in clinical trials and electronic Patient Reported Outcomes (ePRO) data collection methods have evolved over time. The current desire to reduce participant burden and drug development costs, combined with improved technology, has increased interest in having study participants use their own devices ('bring your own device’ or BYOD) to collect PRO data.

However, the uptake of BYOD technologies remains low despite significant interest from the industry in their development. The lack of clear regulatory guidance on BYOD approaches has created a vicious circle: clinical teams are not encouraged to pioneer clinical trials submissions using BYOD-collected data, which limits publications on BYOD success stories, meaning that cautious clinical trial teams are not prompted to take the plunge and broadly adopt BYOD options.

What does the industry need to make a step forward and implement BYOD strategies? How can confidence grow so that study participants can benefit from the comfort of using their own devices to collect PRO data?

This white paper sets explicit expectations as to what BYOD strategies bring and the associated risk and proposes structured help to support successful BYOD strategy decision-making processes and implementation.