Everyone is familiar with the age-old philosophical problem, “If a 
tree falls in a forest, but no one is there to hear it, does it make a 
sound?” Scientifically, yes, but the question is really asking do things
 have meaning and usefulness if they are not experienced. 
When it comes to healthcare technology, a similar question can be 
asked. If a piece of technology does a good job of collecting and/or 
producing data, but it is extremely difficult to use, is it actually 
useful? Engineers can create a capable piece of software, but if the 
users stay away because it’s not intuitive, or it takes too much time 
training users for it to work correctly, then we can’t really say the 
technology is successful. 
In clinical trials, the data comes from patients. These patients 
range from healthy volunteers in early phase studies to very ill 
patients whose symptomatology can directly interfere with their ability 
to participate in study activities such as tracking their medication 
dosing regimen. Despite these facts, it wasn’t until recently that 
healthcare technology companies began adopting a patient-first approach 
to solution design. When AiCure was putting together it’s remote 
monitoring and engagement technology for clinical research, we knew that
 it must be simple and intuitive for patients. For us, there were two 
keys to creating a patient-centered solution that would work.
Empathy
We hear and talk a lot about patient burden in clinical trials, but 
what does that mean? The majority of patients who participate in 
clinical studies are doing so because they hope to find a cure for an 
illness or prolong their lives. They are managing the stress and 
responsibilities of a research study along with their jobs and their 
families – they’re going through a lot. It was important for the team at
 AiCure that we put ourselves in the patients’ shoes. We wanted to make a
 user interface that wasn’t intimidating and allowed patients to get in 
and get out quickly while giving them a sense of accomplishment. It may 
be too much to expect to reduce a patient’s burden, but we can certainly
 work hard to make sure we’re not adding to it.
Accessibility
Above all the system had to be easy to get into and then easy to use.
 The first part was building a solution that can live on devices that 
most patients are already familiar with, namely smartphones and tablets.
 At this point, most people – patients included – are familiar with 
downloading and accessing smartphone and tablet applications. Using this
 infrastructure means less training is necessary.
Once in the app, patients are walked through what they need to do via
 simple, straightforward instructions. For example, patients are 
presented with a set of animations that help explain how to correctly 
take their medication. The app is designed to guide them through dosing,
 utilizing the smart device’s camera to record each dose. The software 
can detect issues with dosing and provide gentle guidance, giving them 
second and third tries to administer the medication in a way that 
rewards effort and preserves dignity. In this way, empathy and 
accessibility work together to acknowledge the reasons why a patient 
might be having trouble and helping them to be successful.
Patients are central to the success of any clinical trial. Technology that engages patients, keeping them involved while accurately collecting data can be of tremendous benefit to sponsors. But for the technology to produce the desired effects, it must be designed with the patients’ experience in mind. By understanding the needs of the patient and working to create solutions that help them fit clinical study participation into their lives without creating new burdens, we can create sustainable study models that produce reliable and accurate data for sponsors.