Susan M. Dallabrida, PhD and Laura Khurana, MPH, ERT
Clinical trial patients know what they want. And, although we know from significant research that patients prefer electronic patient diaries (eDiaries) over a paper-based approach, until now we never questioned how they prefer to interact with this technology. Here we review some of the findings from an ERT study conducted to understand what patients want to see on their screen when completing eCOA assessments for clinical trials.
Survey data from 408 patients with osteoarthritis, chronic obstructive pulmonary disease (COPD), depression, or Type II diabetes were collected in the following categories: patient engagement, compliance, ease of use, and feedback on specific eCOA features. In total, 132 different questions were asked.
The study’s findings point to the need for ‘humanizing’ eCOA screen designs in order to improve patient interactions with the technology. The following findings should be considered when approaching eCOA study design for clinical trial use:
- Patients strongly favored having a screen at the beginning of an eDiary that shows the number of questions and estimated time to completion.
- Patients preferred seeing their progress as they move through the eDiary, either via a graphic progress bar or a “Screen X of Y” message.
- Most patients wanted to see a graphical summary of the symptom data that they report on a daily basis, to see how it changes over time. While this may be appropriate at the end of a patient’s participation in a trial, sponsors should carefully consider whether presenting this data during the trial could unblind patients to their treatment group or otherwise bias their future responses.
- Patients reported that they would be motivated to continue completing a daily eDiary if they saw a screen summarizing their diary compliance when compared to the average compliance of patients in the study or a target compliance.
- Patients also resoundingly expressed a desire for a ‘thank you’ screen at the end of a eDiary.
For additional information on ERT’s ongoing research on the effective use of eCOA to improve and accelerate clinical development, visit ert.com/eCOA.
Susan M. Dallabrida, PhD is Vice President, eCOA Clinical Science & Consulting Services, ERT and Laura Khurana is Senior Scientific Advisor, eCOA Clinical Science & Consulting Services, ERT