Digitally managed clinical trials have the potential to accelerate results report and reduce costs but workflow questions and regulatory questions remain. In many facets of our lives digital data collection has improved services, eliminated errors, and reduced waste in time and resources. Think about the ticketing and check-in process at airports ten years ago vs. today: when airlines put the information in our hands we were able to do the check-in, seat selection, and other work for them. Plus, we were happy to do it. Also consider ATMs, online banking, and retail banking for how we are able to move money, get cash, and get loans by providing data ourselves and get immediate services. When we think about the medical industry, though, very little of the kind of automation created by self-service digital data collection exists. While we can see some patient portals and self-service triage apps appearing in limited uses, large scale use seems very far away. One specific area that digital data collection can, potentially, literally save lives is in clinical research. The use of digital collection tools, primarily mobile devices, in clinical studies is nascent but growing. Evidence indicates that these tools have the potential to significantly improve the quality of research outcomes and reduce the costs associated with such research, but there are still questions about how exactly these tools will work and some of the issues surrounding electronic data collection. To help answer some common questions, I spoke with James Emerson, who is a director of clinical research and helps run a variety of clinical trials.
How are mobile devices being used for digital data collection in clinical research?
For several years now, IT in the enterprise has been moving toward consumerization; that is, people are bringing their own devices to work and many of the same applications are used outside of the office. Clinical researchers have realized that same consumerization of IT that is revolutionizing the way that we work can do the same for research. Trial participants using clinical trial research technology are able to use their own smartphones, tablets, and other mobile devices, which makes it much more likely they will comply with the requirements of the study.
Essentially, depending on the setup of the study, patients simply need to input information into an application, eliminating the need for paper journals or surveys.
While research indicates that most patients actually prefer this technology over other form of data collection, in particular voice response systems, there are still some challenges. One thing that researchers need to overcome are the differences among devices themselves, and how applications actually function on different devices. Training trial participants — and providers — in the use of the application is an important task. Connectivity issues are also a concern, as is privacy. Protecting sensitive personal information is of paramount importance, and researchers are cognizant of the need for data protection protocols and security, both in terms of protecting the devices themselves and in the transfer of data.
Why are digitally managed clinical trials ideal for clinical research?
Digital data collection has many significant benefits. For starters, it reduces costs. Major clinical studies often have thousands of participants, all of whom need to be trained in how to record data and submit it to their providers. That data also needs to be collected and analyzed, often manually. Digital data collection reduces or eliminates the need for many of those expensive tasks. When clinical trial participants are allowed to use devices that they already own and are familiar with, the complexity of the training and on-boarding decreases and compliance increases.
The simplified data collection process also has a significant impact on the overall quality of the study. Again, compliance is a major benefit. Studies have shown that patients vastly prefer mobile data collection over other options like paper journals or interactive voice response systems. It’s simply much easier to input your data into your mobile device and move on with your day than it is to navigate a complex menu of voice response options or fill out a paper questionnaire.
The accuracy of the data collected also improves; when patients use paper journals, for instance, they have a tendency to add additional extraneous information or skip questions, which can affect how the data is analyzed. Not to mention, when the researchers have access to real-time data, they can identify compliance issues earlier on and monitor patient safety more efficiently, improving the overall outcome of the trial.
While digital data collection can improve the accuracy of the data collected, there are some obstacles to overcome. Digital data collection protocols require that researchers consider facets of study design that they might not have otherwise. For example, what happens if a device is lost or stolen? How can we protect that data and the integrity of the study? We need to use a technology infrastructure that complies with regulatory protocols, but that is also easy for subjects to use.
Many researchers are also concerned about equivalence among the devices being used. In other words, are all of the subjects having the same experience when using the application, and how do differences affect outcomes? These are all questions that researchers are considering in their study design.
Can digitally managed clinical trials really save that much money?
The short answer is yes. In 2014, the Department of Health and Human Services released a report estimating that using mobile technologies in clinical trials has the potential to save clinical research organizations (CROs) tens of millions of dollars. The greatest savings come in the later stages of trials, but even in the early stages, mobile saves money.
Are there regulatory issues related to the use of digital collection tools that CROs face?
The FDA is actually encouraging CROs to do as much electronically as possible. That being said, yes, there are some stringent regulations that CROs must adhere to that ensure the accuracy and protection of the data. The FDA has issued guidance on how CROs can capture and use data to maintain those protections.
Are there times when digital data collection isn’t ideal? What about barriers to participation?
While it might seem like everyone on the planet has a smartphone these days, the fact is that there are some people who either do not have access to the technology necessary to participate in a research study via a mobile device or have the skills to do so correctly. It’s important to carefully assess the target population of the study to determine whether digital data collection is appropriate or if more traditional methods would be a better choice.
For example, many older adults either do not have or do not use smartphones, and aren’t interested in learning how to use the application to participate in the research. For someone who isn’t a digital native, using an application to record data could be intimidating or confusing.
Another issue is a lack of access to the internet or cellular service. In many rural areas of the country, access to broadband is still limited, and cell service is limited or nonexistent. Relying solely on digital data collection via smartphone has the potential to exclude viable candidates from research studies, simply because they cannot provide data efficiently. We need to be very careful in how we design studies, and the technological requirements, or risk inadvertently creating disparities within the study population based on economic or geographic situations.
And of course, not all studies lend themselves to self-reporting — and as with any self-reported data, there will always be a margin of error. Researchers need to carefully consider their reasons for choosing digital data collection, and evaluate whether they are ideal for an individual study.
Are digitally managed clinical trials really the future of clinical research?
Yes, we believe so. The fact is, the old ways of doing things are no longer infallible. Using digital tools has the potential to solve many of the long-standing problems within clinical research, including low study recruitment numbers, gender bias, accuracy, compliance, and more. By incorporating digital tools, new, more effective treatments can get to market faster while keeping patients safe and improving their overall health.