In our webinar, Trials in Women’s Health: Best Practices to Drive Time and Cost Savings for Your Women’s Contraceptive Clinical Trial, we discussed how technology can help address challenges common to patient enrollment, compliance, and monitoring.
One form of technology that is gaining popularity and acceptance in a variety of clinical trials, but particularly in women’s contraception trials, is the electronic diary, also referred to as electronic patient reported outcomes (ePRO). To gauge the potential interest and current use of electronic diaries across our webinar audience, we asked attendees: Have you used, or would you consider using, ePRO for your contraception studies?
34% said, “We are currently using ePRO”
58% said, “We would definitely consider using ePRO for our upcoming/next study”
8% said, “ePro is not something we would consider using for our upcoming/next study”
Considering that compliance with daily recording of data is of utmost importance, particularly in clinical contraception trials, it’s easy to understand that more than 90% of the audience have been, or are considering, using ePRO. Historically, (women’s) contraception trial participants kept written diaries; however, these can be cumbersome and impractical. As a result, they may not be completed on a daily basis, and participants may attempt to backfill their diaries at a later date, resulting in recall issues. For example, if the written diaries are only collected monthly, say, during a participant’s scheduled office visit, the data could be significantly compromised.
The use of e-diaries reduces a participant’s burden associated with documenting product use, endpoints, side effects, and other required data, and significantly improves compliance and retention. What’s more, there is flexibility within and between devices for communication. The e-diary can be developed for use on any web-enabled device (e.g., phone, tablet, PC), and can be delivered via an application for a mobile device or the Internet for any device. Responses can be entered in response to binary (e.g., yes/no), multiple choice, or free text questions, allowing for further flexibility in data collection while simplifying the process for the user. Entry can be conducted once daily, and reminders for missed entries can be automatically delivered via email or text message, and the participant can respond at their convenience, removing the need for phone calls and follow-up scheduled at the researcher’s availability.
However, there are challenges associated with the use of ePRO that must be accounted for when planning any trial leveraging this type of technology. We fielded a great question during the webinar Q&A session: Is the FDA supportive of using patients’ devices (cell phones, tablets, etc.) to record daily diary entries, rather than standard devices provided by the vendor?
In my experience, I have not had specific feedback regarding the use of personal devices from the FDA. However, looking at the issue from a more operational angle, using women’s personal devices can be problematic because you have to take into account the individual data plans for each participant. It can be a cumbersome process to reimburse participants for their text/data plan, especially when each plan has a different amount of coverage. Since it proves to be logistically challenging, I recommended the use of a vendor-provided device. They’re not necessarily difficult to access or too bulky. Women also don’t typically worry about carrying around more than one phone and/or device. So while I haven’t had any feedback from the FDA discouraging using personal devices, I would discourage it from an operational standpoint.
At the end of the day, although there is higher initial investment, an e-diary that is easy and straightforward to use reduces participant burden and engages the participant, resulting in increased compliance, fewer missing data, and improved retention. In addition, there is increased reliability and consistency of data, with approximately 90% diary completion rates, much higher than those with paper-based diaries.
For more information on best practices to drive down cost and time savings during your women’s contraceptive clinical trials, feel free to watch the recorded webcast, read the eBook, and download the infographic.
Darcy Forman is the senior director of project management at Clinipace.