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Meta-Analysis: ePRO Compliance and Retention for Patients using their own Smartphones in Fully Decentralized Clinical Trials



Susan M. Dallabrida PhD, Matty Culberth-Notaro BSN-RN 

Objective

Traditionally, electronic patient-reported outcomes (ePRO) were collected on provisioned devices provided by clinical sites. Patient retention in clinical trials depended largely on the sites’ ability to engage patients during visits. The arrival of “bring your own device” (BYOD) models has enabled patients to complete ePRO in clinical trials using their own smartphones. There has been considerable speculation in the industry as to how such a model would impact study retention and ePRO task completion. Herein, we show the results from a meta-analysis of six (6) clinical trials across therapeutic areas in which patients completed diaries using their own smartphones.

Method

Patients completed daily ePRO assessments between 2018 and 2021 using the ObvioHealth app on their personal smartphones (Android or iOS) in therapeutic areas that included: urinary incontinence, dermatology, lower urinary tract symptoms, menopause, hypertension, and infant nutrition. 


Results

Study durations ranged from 4 to 19 months, with an average study period of 10.5 +5.7 months. In total, 752 patients were enrolled with 658 patients completing their respective study. The overall retention rate across the six studies was 88%. The average weighted ePRO compliance was 90% across the six studies. 

Conclusion

In summary, these data show that retention of study patients in a fully decentralized clinical trial is relatively high at 88% compared to the traditional site-based industry benchmark of 70%. Similarly, ePRO compliance of 90% suggests that patients are willing and able to use their personal smartphones to remain engaged with and compliant in a clinical trial. It is surmised that in addition to a user-friendly app, automatic notifications and a live virtual clinical support team regularly in contact with participants to encourage engagement and retention are critical factors in achieving these improvements.