Introducing mHealth Tech to Epilepsy Patients in Clinical Trials
Clinical trials are often criticized for being behind the times, and neurologists working with epilepsy patients aren't an exception. Neurologist John Hixon recently spoke at the NYAS conference, and reflected on the current system and opportunities in mHealth.
Epilepsy patients in clinical trials often use a “self report” system that depends on patients to recognize their seizures and log the events in a paper diary at a later time. The process often leads to “the parking lot effect” with patients filling out diaries in the parking lot outside of their doctor’s office before an appointment.
Since epilepsy patients do not always detect their seizures, Hixson considers diary entries to be “fraught with errors.” There’s plenty of room for improvement and mHealth tech may be a source for opportunities.
- Medication reminders
- Tools to report adverse events and reactions (e.g. side effect of a new medication)
- Real-time data with time stamping
- Disease education
- Social networking
These features add value with a superior user experience from the current system, a criteria Hixson highlighted as being necessary to adopt a new tool, while also engaging the patients in care management.
Considering these tools improve patient engagement and collect new info, what’s the hold up for using them in trials? Precedent. No one wants to be the first to use mobile tools in a trial out of fear that the FDA may not approve it, and the time and money will be lost. The existing system has problems, but it’s resulted in FDA approvals in the past.
The other major hurdle is the quality of the devices being introduced to epilepsy patients. Some devices have a 90 percent rate of detecting grand mal seizures, but aren’t equipped to pick up smaller episodes such as staring spells. Companies are continuing to introduce new and improved devices, but we’re in the early days of mHealth devices equipped for trials.
Despite holdups, the field is quickly evolving and become more sophisticated to meet the needs of these patients. As medical devices continue to improve, and other clinical trials adopt mHealth technology, the modernization will extend to clinical trials for epilepsy patients.
According to Hixson, the key to introducing mHealth devices in clinical research is data quality. When mHealth data is considered equal or superior to the current data, mHealth tech will have a more compelling reason to be used in clinical trials.
Medidata and my team, Medidata Patient Cloud®, has started the conversation, helping our customers implement wearables in less risky early phase environments. We’re excited to see where the research goes from here.
Interested in learning more? Check out the full version of this article on Forbes.