The Internet of Things (IoT) is an umbrella term that covers devices that collect and exchange data with other devices over the Internet. And according to the experts involved in launching it into clinical trials, the sector is at a turning point.
In the past three to four years, the sector has experimented with new forms of data capture, says Medidata solutions expert for digital vital signs, Ben Shalatka. Schlatka notes that it is now in a phase of frequent and high adoption of structured research questions.
In clinical trials, the most common IoT devices are electronic clinical outcome assessments (eCOA) or patient report assessments (ePRO), sensors, and wearables. The areas with the most clinical trials using IoT are cardiovascular disease, central nervous system disorders, chronic diseases, dermatology, diabetes, and pain management, notes Gabriel Brambilla, CEO of healthcare technology company Alera Health.
While IoT integration is being accelerated in experiments, many issues remain. With devices collecting an unprecedented volume of data, are sponsors or contract research organizations (CROs) equipped to use that data to enhance the odds of a successful trial? Although eCOA and ePROs have been incorporated into clinical trials for years, there are issues with decentralization. For sensors and wearables, with so many options available in the market, how should sponsors choose the right approach?
IoT Clinical Trial Data Types
There are two types of IoT data collected in clinical trials: The first is data collected according to the protocol, while the second includes information that can be used to help design other trials in the future, Brambilla says. For example, the data could help target the right patients for the success of a future trial, he explains.
From a different angle, Shlatka says the first type of IoT data is one that one would have previously collected on a test site. Now, as a decentralized form of data collection for the same data points, data collection occurs frequently. The second type, he adds, is new, informative data about the participant’s unstructured environment, which puts treatment data in a new context.
“The clinical trial industry is still grappling with the data we have,” says Gillian Levock, Medable’s senior vice president and general manager of Connected Sensors and Digital Meters. She adds that it is essential for the sector to use the data carefully because the participants made an effort to report the data.
IoT technology helps collect data that can answer primary endpoint questions, says Matt Bonham, AstraZeneca Head of Research and Development in Digital Health and Biopharmaceuticals. Levock adds that IoT data can also provide exploratory data that can be used retrospectively to find vital indicators for pipeline development.
But a fishing trip should be avoided. Poonam cautions that it is not optimal to collect all kinds of data and then find a meaningful trend. He adds that the scientific process must be protected, by starting with a clear hypothesis and data collected in an orderly manner.
There are exceptions. For example, when using data to predict the onset of heart failure, critical parameters of heart function are known, but which of them will be more or less important is not known, Bonham explains.
Patients should be informed of the reason for collecting the data, and if there is an exploratory component, it should be thoroughly explained, Poonam says. Levock adds that when deciding which data to collect, it’s important to find measures that matter to the patient.
eCOA and ePRO: The Essential Internet of Things in Experiments
One of the most popular IoT approaches in clinical trials is the use of eCOA, or ePROs, says Bryan Lubel, executive vice president of connected health at IoT provider KORE Wireless. according to Clinical trial arena exclusive Decentralized Clinical Trials Adoption Tracker (DCT)The use of eCOA and ePRO increased sharply from 2020 to 2021, driven in large part by more widespread use among CROs. Lobel notes that in clinical trials, smartphones or tablets are secured to be a single-purpose managed device.
While ePRO and eCOA have been used for years, what currently differs is how they are used. Previously, these methods, although electronic, were used at clinical trial sites, and thus the study was not decentralized, Brambilla explains. He adds that these methods are now used in the patient’s home.
There are many issues that sponsors need to manage. One is the cost and time required to invest in such devices, Lobel says, that won’t affect the drug development timeline. He adds that there are also questions regarding the logistics of delivering the device to a patient, and how quickly the data collected can be validated.
To incorporate eCOAs or ePROs into clinical trials, companies either buy other companies that already have the technology, or develop it internally from scratch, Levock says. The advantage of the latter, she adds, is that the technology is synergistic across any of the decentralized experimental modules the company is already using. Users will not have to switch apps if the experience contains different DCUs.
Patient compliance is another issue; How often patients enter the required data, and if it is the patient who enters the data, Poonam notes. He adds that simple methods of identification such as fingerprints and facial recognition technologies help alleviate this concern. Patients should be informed of why and how the data is used to ensure high participation.
Long list of sensors, and wearable options
Meanwhile, sensors and wearables are a hot topic in the clinical trial sector because, so far, they haven’t been taken seriously, Lobel says. “It was considered a science project.”
Lobel adds that there is a new appreciation that the sensors provide a much broader and deeper view of the effectiveness of the investigation approach. According to our DCT certification tracker, the use of remote monitoring with sensors and devices increased an average of 60 trials per year between 2010 and 2016, Jump to over 250 in 2021.
The challenge for sponsors is the abundance of hardware options available. and all These devices have their own roadmaparchitecture, and Bluetooth configurations, among others, notes Livock.
Poonam says AstraZeneca only uses gold-standard hardware, meaning this approach already has regulatory support. He points out that if a device is to be used outside of its intended use, there is a verification process that compares it to the gold standard. AstraZeneca has a hardware catalog featuring tested and approved devices, as well as those that don’t meet the standards, so it’s easy to find the right device when designing a trial.
What’s exciting about IoT devices, Brambella explains, is that proof-of-concept on their usefulness is usually collected in the real world, before being incorporated into clinical trials. Thus, the more these devices are used in practice, the more likely they are to also be used in studies, he adds.
Bringing sensors and wearables into trials could depend on geography. For example, there can be two pulse oximeters with identical features, but one is certified in the United States and one in the European Union, Lobel adds. An experiment can contain data from multiple types of oximeters, and each program can only capture or display the data in a certain way, and thus needs integration work, he notes. He adds that data privacy also varies according to geography, noting that, for example, data collected in certain countries should remain there.
To enhance participant participation, the sensor or device must discreetly fit into everyday life, Levock says. For example, expensive devices may not be ideal in developing countries because they can draw attention to the user, and therefore alternative solutions are needed. Ultimately, she adds, while choosing a sensor or wearable option, sponsors should ask this basic question: “Why do we collect data and why is it important?”
When it comes to the Internet of Things, does the size of a clinical trial sponsor make a difference? Brambilla says large drug companies and MedTech companies may be more open to exploring new ways to collect data via a remote approach. He adds that smaller companies, meanwhile, have one chance of a successful trial, and are therefore more risk averse.
Poonam disagrees: While big pharma may have an advantage in their ability to drive innovation, the primary goal of all sponsors is to reach a larger proportion of society. This, he adds, benefits everyone, and especially the patient, as participants who are highly involved in trials generally do a better job. “Technology is there to make experiments easier.”
- While the Internet of Things opens many data possibilities in clinical trials, sponsors must protect the scientific process by avoiding data hunting trips.
- While eCOA and ePROs have been used for years, moving devices to a patient’s home is decentralizing the technology.
- With a wealth of sensors and wearables available on the market, sponsors must be thoughtful and comprehensive about which approach to incorporate into experiences.