Over the last few years, smart, connected products have become part of our everyday lives. We can hardly remember a time when our phones, watches, and TVs were not connected to the internet and providing us with real-time data. The phrase “Internet of Things” (IoT) has developed as a way to categorize the growing number of smart products that have saturated the market. With this growth, we are gradually seeing smart technology’s presence in Phase I clinical trials. With time, we will see its presence grow exponentially as more clinicians begin to realize the immense potential that smart devices have in clinical research.
Smart devices have the ability to connect to the internet, gather their own data, analyze that data, and transmit it to other machines wirelessly. There is no limit to what can become a smart device: watches, tablets, activity trackers, and automobiles are just the tip of the iceberg. According to Gartner, a technology research firm, the number of smart objects worldwide is projected to be roughly 25 billion by 2020. Currently, there are 5 billion in existence, which means the growth is expected to be 500% over the next 5 years.
The pharmaceutical industry is already starting to use things like pill-shaped micro-cameras that can pass through the human digestive tract and transmit images and data wirelessly, pills that have sensors that measure medication adherence, and hip replacements that can detect falls and send messages to healthcare providers. Other devices, like wearables and smart skin patches, can send messages and data from a patient to the hospital or clinic. Not only do smart products have the ability to collect and analyze data, but they also have the power to learn and develop according to the individual using them, which can help clinicians better monitor their subjects. These technological advances are still in their infancy, and the next few years will bring more products that can help in early phase studies.
Currently, there are a few major factors that can derail a Phase I study, such as increased operational costs, corrupt data, and endangerment to subject health. The Internet of Things promises to help mitigate these risks and change the way Phase I clinical trials are conducted in a myriad of ways, some of which are:
- More accurate and continuous monitoring that will lead to better data. Phase I is the most risky of the four clinical trial phases because it is testing safety on healthy patients. With this higher risk comes the need for more accurate and continuous monitoring, which can be done with the adoption of smart technology and wearable devices. There are always errors associated with human data collection, some of which can be avoided by embracing new technology. With patients utilizing products like Proteus’ ingestible pill sensor to detect medication adherence and provide real-time data on subject health, or Google X’s wearable that will provide medical-grade biometrics, clinicians would be able to constantly monitor how patients are doing during their trial, even when they are not at the clinic.
- Patient recruitment and retention. Smart products, such as wearables or ingestible pills that track concordance, have the ability to collect and analyze data from anywhere in the world, which will help with patient recruitment and retention, something that has long been an issue in clinical trials. Currently, to participate in a clinical trial, patients must be in the same geographic area where the clinic is located. With the adoption of smart technology, certain Phase I studies could limit the number of times their subjects need to go into the clinic. Having the ability to remotely monitor subjects would provide both the clinician and patient with more flexibility.
- Enhanced patient experience. Using activity monitors, ingestible smart pills, and other new clinical trial-centric smart devices will provide patients with constant insight into their health and the knowledge that their well-being is being constantly monitored by clinicians. This will make them feel more at ease when entering into early phase clinical trials.
While the Internet of Things has already begun to permeate clinical trials, it is not as mainstream as it is in other sectors because the technology is still evolving and advances still need to be made. Clinical researchers have also had a history of being hesitant to adopt new technology, as the accuracy of the data collected in clinical trials is critical and there is no room for error. Over the last 10 years, however, we have seen a slow, but steady, shift to the adoption of cloud-based electronic data capture (EDC) platforms, like Medrio’s, to improve data collection and management. The fact that this shift has taken so long can be attributed to clinical researchers’ apprehension towards trying new technology. Although smart technology and wearables have received a similar initial response from clinical researchers, some are beginning to use them to collect biometric data on trial subjects because these devices have the ability to collect better data and improve patient experience. We can expect to see the adoption of these technologies increase as clinicians begin to see the significant benefits of collecting data from these devices, and the huge opportunity that the Internet of Things presents to the clinical research industry.
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