The area of clinical data collection has seen an influx of rich, digital solutions in recent years, and more continue to enter the marketplace. The plethora of devices, apps, and solutions is aiding in data collection – some within the context of clinical trials and healthcare, others for patients themselves as users and owners of their own data. In 2015, the FDA approved 299 studies that had incorporated wearables into their data collection efforts. This is quickly becoming the norm.
There are clear advantages to using “smart” technology for data collection. The data is, in some cases, real-time and accurate, so you aren’t subject to human error in reading and recording data. Also, these devices allow constant recording of patient data, during and between site visits, that can even reduce the need for on-site visits themselves. The use of these devices and apps has the potential to reduce costs and errors, and improve the overall accuracy and timeliness of data. The possibilities are endless.
Below are just a few examples of digital tools that can be leveraged for clinical data collection:
Exco InTouch is a patient engagement platform that supports patients from recruitment through study close. We all know that supporting patients during a clinical trial is critical, so Exco InTouch has built a strategy to support patients, from simple medication adherence and site visit reminders to a tailored motivation and educational support plan. This is delivered directly to each patient’s device, in order to seamlessly integrate clinical trial participation into their everyday life. It can also link directly with various connected devices to capture data along the way.
AiCure is a company that has developed a patient medication adherence app that goes much further than setting up schedules and reminders. While it does those things very well, it also includes functionality that uses the camera on a patient’s device to confirm medication adherence. As the patient holds up the medication, the camera identifies the medication and then watches the patient put the medication in their mouth and swallow. It logs these events, and provides the information back to the sponsor.
Medic is a company that has developed a smart toilet. This data capture device can be installed either at a clinical site or in a patient’s residence for long-term studies. It can provide meaningful data, such as blood pressure, EKG, heart rate, weight, body fat percentage, urine flow rate, urine volume, fecal volume, and VOC analysis. It even has a fan system that draws in fumes and smells to analyze them for health data. This smart toilet and all of the data it captures can be integrated with your clinical data management or electronic data capture systems, which can dramatically reduce the time it take to record all of these data points on case report forms. It also eliminates data entry errors, since the data is being sent directly from the device to the system, with no human intervention.
Roche has developed a mobile app for those with Parkinson’s disease (PD) that complements traditional physician-led tests. This smartphone technology continuously measures a patient’s symptoms. Patients are asked to follow a daily routine with the app, using it every day for the duration of the trial. The trial consists of six active tests, followed by passive monitoring. These assessments are designed to provide information on a patient’s symptoms, their progress, and the impact on their daily life. Patients are asked to use the app for screening, dosing and follow-up, which may last up to a total of 32 weeks. Without having to bring patients in regularly for site visits, the app offers incredible insight into the disease and the effectiveness of treatments, and is providing Roche with a significant cost savings.
Proteus has developed an ingestible sensor that is as small as a grain of sand and can be embedded in the medication itself. Once the medication is swallowed, the sensor triggers data collection and provides valuable data to the patient, physician, and sponsor. Patients can easily monitor their medication-taking patterns using their mobile devices. Physicians can access objective data that enables them to modify treatment therapies and refine dosages. Health systems and sponsors are able to measure treatment effectiveness and optimize therapies across patient populations. The sensor also measures and records the patient’s activity and rest data, which can weigh in on the treatment effectiveness. While the data capture element ensures the accuracy of data, it also provides a valuable and objective measure of adherence. Additionally, Proteus incorporates a portal that helps facilitate the patient-physician relationship, maximizing the health benefit of the technology.
The above are just some of the examples in this area, but there are so many more. We continue to be very excited about the ways in which connected devices and apps are transforming clinical trials and healthcare.