CWWeekly presents this feature as a spotlight on issues that executives in clinical research face. This week, writer Karyn Korieth spoke with Laurence Burke, vice president of Operations, Exco InTouch, which provides digital patient engagement and data capture solutions for clinical research and healthcare providers.
Q: How can mobile technologies benefit the conduct of clinical trials?
A: The most obvious benefit of mobile technologies is the ability to improve compliance through the provision of alerts, reminders or even instructions to patients on how to complete procedures or diaries. As trial designs become more complex, sponsors have seen a fall in compliance levels amongst both investigators and patients; however, using mobile technology can help address this. Patients are more likely to attend site visits, complete patient reported outcome (PRO) forms and take their medication on time when they receive mobile reminders.
We are not suggesting that technology can replace the role of the investigator and site staff in aiding compliance. The site coordinators are the people who reach out to patients regularly to make sure they are attending visits or know what tasks they should be doing. We can give sites tools that help them. We can supplement their work by helping them target the patients who are going off-drug or not being compliant by capturing the data real-time and allowing investigators to see which patients have missed assessments. But you can’t take away the need for a coordinator to build a relationship with a patient. Mobile technology is there to support the coordinators that do their jobs, build relationships with patients and stay on top of protocol.
Real-time data also allows sponsors to focus their resources on sites that might be having difficulties with the protocol. Sponsors can be alerted if a site misses a procedure or if they have a higher number of patients that have gone off treatment. Clinical Research Associates (CRAs) can then step in and help with additional training, which may prevent an adherence issue before it arises. Ultimately, anything that improves the quality of the data is going to benefit the sponsor. Anything that reduces the number of patients going off treatment or being lost to the project is going to be a benefit, and will contribute toward reducing the cost of the trial.
Q: There has been some controversy in the industry about the Bring Your Own Device (BYOD) model, which allows patients to use their own smartphones to complete diary assessments or other data intended for regulatory submission. Questions have been raised about whether data collected on different types of smartphones for the same study could introduce bias. Is this still an issue?
A: It’s still a hot topic. Although pharma companies are a little conservative about adopting BYOD in a clinical trial setting, it is becoming increasingly more common both within clinical studies as well as within the post-marketing environment. There are studies running right now that incorporate BYOD methodologies and give patients who have their own devices the option of loading an app from the Play Store or the iTunes Store and participating with the device they know and love.
We are involved in a trial with the University of Sheffield in the U.K. where they are looking at data equivalence regardless of screen size or device. Whether you are using a smartphone with, for example, a four-inch screen or a tablet with a larger screen, there is equivalence. Other work in progress will show that the BYOD approach will work.
Q: What are the greatest barriers to wider adoption of mobile technologies in clinical research?
A: Many investigators and sites had a bad experience with early technologies. Early EDC systems were difficult to use. Having had their fingers burned, clinical researchers can be reluctant to step into the technology environment again. That is where we need to provide reassurance. We are addressing this by bringing a simple approach to technology and design. When we are asked to develop an application, we work hard to keep that application simple and keep its usability straight-forward so that sites and patients can adopt it easily. Many clients will want to use mobile technology in a trial for a therapeutic area that has an elderly population, for example. They begin the trial feeling nervous and concerned about the effect that might have. But if you can get the design right, and know who the target user is, you can easily overcome perceived problems.
Mobile devices will increasingly be used in clinical trials. The industry will go the same way as every other industry and adopt mobile technology. The technology has become simple to use and the uptake in mobile phone usage by the general population is massive and global. I can only see more of that in the future.
This article was reprinted from Volume 20, Issue 11, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »