By Celeste A. Elash, vice president, eCOA Science and Carol Tester, vice president, eCOA Partnerships
Regulatory and industry focus on patient-centricity and the patient experience challenges sponsors and providers to enhance patients’ clinical trial experience and reduce patient burden while ensuring data integrity. Technologies such as mobile health, remote monitoring, data analytics, and a host of others are flourishing in our industry, particularly during the COVID-19 pandemic. While those advancements do enable trial efficiencies and richer data sets, we continue to look for ways to make trial participation more manageable for our patients.
The concept of “Bring Your Own Device” (BYOD) – or having clinical trial participants use their own smartphone to record their patient-reported outcome data – is a fairly recent development. The ubiquity of smartphones has the potential to revolutionize eCOA data collection in clinical trials with BYOD by minimizing patient burden and trial costs, while enhancing patient compliance and data integrity.
It is estimated that more than 85% of Americans1 own smartphones and 73% of people in other developed countries and 24% 2 of those in developing countries own smartphones. Increasingly, researchers are exploring BYOD strategies and while trials have successfully deployed this model for studies collecting key endpoint data, some CROs and sponsors are still hesitant because of the absence of regulatory guidance and of the unknowns related to patient acceptance.
Sponsors and CROs considering BYOD should evaluate a range of factors and it is recommended you seek regulatory input early and often to get advice and alleviate concerns before selecting an ePRO strategy. In this article, we discuss some of the key considerations for sponsors who are deciding whether a BYOD strategy is right for their trial.