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The Internet of Everything (IoE) is having an enormous impact. With Gartner listing the IoE as one of the top ten strategic technology trends, and the number of smart objects worldwide projected to be in the region of 25 billion by 2020, the phenomenon is bringing together people, processes and data to make networked connections more relevant and valuable than ever before. Expanding on the concept of the Internet of Things, we are not just talking about connecting physical devices anymore but quite literally bringing everything together on a single network. With the IoE now taking center stage across all major industries, from financial and banking services to retail and telecommunications, is it time that the clinical trials industry embraced the new capabilities, richer experiences and unprecedented economic opportunities that the IoE can bring?

The IoE and Clinical Trials

Clinical trial complexity has increased exponentially due to geographical spread, more patients and more data to manage. As the number of global clinical trials has increased, it has become increasingly expensive and time-consuming to monitor sites and patients via on-site or face-to-face visits. This has brought increased pressure to monitor clinical trials more effectively, while also driving the need to use technology more efficiently to optimize processes.

The IoE is blurring the line between clinical trials and digital health. It enables medical and wellness devices, sensors (motion, temperature), wearables, implantables, and applications to connect to a health care system via the internet. In the context of clinical trials, this presents new opportunities to make studies more efficient, more cost-effective and less intrusive, and has the potential to speed up the time it takes to research and develop new treatments. It adds additional layers of real-time objective data such as activity measures, weight, temperature, heart rate, to subjective data collection, such as electronic clinical outcomes assessments (eCOA). This constant flow of rich data allows investigators to remotely manage a patient’s health, and has transformative potential for efficacy studies into new therapeutics.

At the core of the IoE strategy is the use of remote patient monitoring solutions which take research beyond dedicated investigative sites by using sensors and devices to capture a stream of data that paints a picture of daily living. Data may be gathered via wearable and standalone biometric sensors, and there is even the opportunity for sensors to be installed in patients’ homes, including room sensors, and sensors that could detect when a subject gets in or out of bed, opens the refrigerator, flushes the toilet, takes medication, leaves or returns to their home. When combined, the data from these types of sensors has the potential to unobtrusively, (i.e., without the use of cameras), map a baseline of daily activity and changes to that baseline. For example, a heart failure patient sleeping upright in a chair rather than in a bed.

These measures allow patient data to be collected continually as individuals go about their everyday lives and facilitates a continuous system of proactive patient management for the duration of a clinical trial. Remote patient monitoring may also significantly increase the number of patients that can be handled by investigators, and with the design of new software, investigators could potentially remain connected with patients in any location.

Real-World Advantages

The digitalization of clinical data collection and surrounding processes is enabling investigative teams to collect real-world data for deeper insight into new drug response. More accurate and continuous patient management may lead to better data quality, and by arming patients with wireless wearables, medical devices, sensors and mobile applications, it is possible for investigators to remotely collect activity information and key biometrics. From a reporting perspective, the IoE removes the need for any manual input of data, allowing data to be both collected and analyzed automatically.

The IoE brings ease-of-use and increased focus on the individual patient experience, supporting a patient-centric approach to clinical research. It could also offer improved means of maintaining patient safety and trial integrity by using a data-led approach to managing patients and responding to adverse events. Investigators may be provided with the information needed to intervene at the first sign of potential harm, and patients would likely feel safer in the knowledge that they are constantly being monitored.

By facilitating the collection of richer data, the IoE may help to identify patients that are most suited to a trial protocol -- meaning that it could redefine patient recruitment. Once patients are enrolled in a trial, the use of connected devices, such as wearables and sensors, means that data may be more easily collected from patients without causing unnecessary burden and inconvenience. This has the potential to increase both patient retention and patient adherence to trial protocols.

Are There Still Barriers?

While embracing the IoE presents multiple advantages to the industry, as in any transformational change there are still some obstacles which will need to be overcome or circumvented as more and more organizations adopt this type of strategy. Patient privacy and the security of networks and devices are going to be critical to the success of IoE initiatives. These issues will continue to evolve and will need to be resolved as the industry takes steps forward, and there is a considerable amount that can be learnt from other highly regulated industries, such as banking, which are already readily embracing the IoE. While the IOE is both easy-to-use and to deploy, equal access to technology remains a challenge and something which requires greater focus from the industry.







Questions also remain about what should be done with such large volumes of data once collected. In a typical clinical trial, data are collected from a patient once or twice a month. With new technologies information is collected on a much more frequent basis. For some measurements, such as temperature or blood pressure, data collection can even be continuous. While integrating sensors and devices adds complexity with the reward being more data, sponsors and CROs now need to look at what exactly is being collected, how it is analyzed and how the endpoints collected can identify if a drug is achieving its targets for safety and efficacy.

The process of validating an IoE approach is a relatively new concept for clinical trial sponsors and CROs, and fostering understanding of implementation and on-going management of the lifecycle will be a critical step in ensuring successful adoption. Many will likely see value in working with providers that have already developed tried-and-tested methodologies for an IoE approach. Working with a mature, experienced provider that truly understands audit, validation and data security, will enable sponsors to benefit from expertise that spans the entire process. However, sponsors should be wary of emerging companies that are jumping on the IoE bandwagon without having the knowledge-base or clinical pedigree to see projects through successfully.

Despite the barriers, capturing data in real-time, minimization of site visits and remote patient monitoring have already proved their worth. The IoE takes this to a new level and early adopters will potentially see the biggest rewards and stand to achieve the greatest competitive advantage.

Final Thoughts

The IoE enables investigators to focus on taking advantage of new opportunities to capture richer, more useful data that better serves the needs of today’s clinical trials. As the FDA approves more validated wearable devices for use in clinical trials, the use of the IoE is expected to increase. Like any strategic change, there are still obstacles to overcome, and while proper integration and implementation with reliable data management systems is critical to success, to be truly beneficial, investigators must move beyond looking at the IoE from a functionality perspective to assessing its potential to revolutionize the patient experience.

This article originally appeared in the April 2017 Global Forum.