Compliance with the protocol is the most important requirement to be met in order to have a successful clinical trial and accurate data. Using paper based Patient Reported Outcome (PRO) measures commonly known as paper based patient diaries is often a threat to having accurate data. When the data is filled out on paper and brought to the study center for the next study visit, it is easy to fake compliance. The famous “parking lot effect” when the patients back fill their diaries right before they step into the doctor’s office is the most common deception. A study done by A. Stone and colleagues (2002) on paper vs. electronic diary compliance captures this effect along with other deceptions such as forward filling of diaries and misleading self-evaluations of diary compliance. Real compliance with paper diaries in this study turned out to be only 11%, which makes it obvious that data from paper diaries is unreliable.
Furthermore, the FDA’s PRO Guidance states: “If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected’’ (U.S. department of health and human services food and drug administration, 2009). With being able to regulate patient diary time windows, and having reminders and time stamps with electronic diaries, it is easy to satisfy the FDA guideline. With paper diaries, this is practically impossible and the sponsor risks having data that does not satisfy the needs of regulatory authorities.
In addition to satisfying regulatory requirements, ePRO or electronic patient diaries can improve patient engagement and serve additional functions such as reminding the patient to take the medication and increase medication compliance, and providing feedback of the patient’s diary compliance and health state to both the investigator and the patient. We have previously introduced an algorithm to assess the submitted diary data from COPD patients, and setup automated real-time notifications to the investigator when a COPD exacerbation was anticipated. Having health monitoring in the study and timely follow up on symptom worsening improves patient engagement in the study, where the patient is more likely to be compliant with diary (ePRO) submission to receive the benefit of their disease being monitored and an additional level of care.
If you are looking to use an ePRO solution for a study, get in touch with us and discuss how to make the most out of ePRO in more detail. HealthDiary has been providing Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations since 2003. To benefit from our experience, please contact us today.