The adoption of connected devices in clinical trials has experienced a significant surge since 2020. Driven by the need for more efficient and accurate data collection, sponsors and CROs have begun investing heavily in devices that can help with remote monitoring capabilities and improved patient engagement. These devices, which include wearables, sensors, and mobile apps, are revolutionizing the way clinical trials are conducted, enabling researchers to gather real-time data and gain deeper insights into patient behavior and treatment outcomes.
According to a report by Grand View Research, the global connected device analytics market for the healthcare industry is projected to grow at a staggering compound annual growth rate (CAGR) of 28.9% from 2022 to 2030. This remarkable growth can be attributed to the increasing demand for real-world evidence, the need for remote patient monitoring, and the growing emphasis on value-based care models.
Connected devices offer numerous advantages in clinical trials, such as continuous data collection, reduced patient burden, and improved adherence to study protocols. By leveraging these devices, researchers can monitor participants' vital signs, activity levels, and other relevant parameters without requiring frequent on-site visits, thereby enhancing the efficiency and quality of data collection.
A brief overview of connected devices
The U.S. Food and Drug Administration (FDA) defines a connected device as "a device designed to connect to and have persistent, operationally critical functionality enabled by communications with other products or technologies over a communications network."
In the context of clinical trials, connected devices can be further defined as per the FDA's guidance on "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11":
Clinical trial-connected devices refer to electronic systems and software used to create, modify, maintain, archive, retrieve, or transmit clinical trial data, which may include:
- Electronic Case Report Forms (eCRFs)
- Electronic Patient-Reported Outcomes (ePRO)
- Wearable biosensors and medical devices
- Mobile apps and software used for data capture or transmission
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) addendum provides additional guidance on connected devices in clinical trials, referring to them as "Mobile Technology" defined as:
"Mobile technology refers to the portable or wearable tools used in a clinical trial for the collection of clinical trial data (e.g., mobile/smartphone, personal digital assistants, tablets, home-use instruments) and any related processes or software applications."
Thus, clinical trial devices encompass a wide range of electronic systems, wearables, sensors, and mobile applications that enable remote data capture, monitoring, and transmission of participant data during a clinical investigation.
Paper data is inherently risky and prone to error
Simply put, clinical trial data collected through paper often falls short of meeting basic clinical trial ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) standards due to inherent limitations in their manual nature.
Data collected through paper forms (often clinical outcome assessments (COAs) are always at risk of failing to be attributable to the participant as they lack embedded attribution mechanisms, making it challenging to trace data back to its source reliably. Handwritten entries contribute to issues related to legibility, introducing the risk of misinterpretation and transcription errors. The contemporaneous nature is hindered by the delayed nature of data entry and the potential for retrospective completion, undermining the real-time aspect of data capture.
Originality is jeopardized by the susceptibility to alterations, loss, or damage of paper documents during the course of a trial, most notably due to stains, ink smudges, tears, or missing items. Lastly, achieving true accuracy is impeded by the manual data entry process, increasing the likelihood of human errors and compromising the overall integrity of the data. In contrast, electronic Clinical Outcome Assessments (eCOAs) and connected devices address these challenges by offering built-in features that align with ALCOA principles, ensuring data reliability, traceability, and integrity throughout the clinical trial process.
A real-life example of this “bad data” can be seen in “forward filling,” where participants report completing paper diaries about their treatment outside of the required research windows. A 2002 study indicated that 45% of patients in a pain study forward-filled their data at least once (“Patient Non-compliance with Paper Diaries,” Stone, A., British Medical Journal, 2002).
Real-time data: Connected devices’ most significant benefit
Perhaps its greatest asset, connected devices offer sponsors and CROs the ability to collect participant data in real-time as they go about their daily lives. Because of its timing and continuity, real-time data helps foster better understanding, oversight, and decision-making for almost every trial facet.
One of the primary advantages of real-time data in clinical trials is the ability to make prompt and informed decisions. With the continuous influx of data, researchers can identify trends, potential safety issues or concerns, and opportunities for trial improvement without delay.
This is in stark contrast to only receiving trial data and insights from participants at the time of their visits.
Other benefits of connected devices
Connected devices like wearables and sensors are transforming clinical trials by offering several advantages, these include:
- Continuous data collection: Wearable devices can continuously monitor and record various health parameters like heart rate, physical activity, sleep patterns, etc. This allows researchers to capture data in real-time, providing a more comprehensive picture of a participant's health status throughout the study period rather than relying on intermittent check-ins or self-reported data.
- Remote monitoring: Connected devices enable remote monitoring of participants, reducing the need for frequent in-person visits and increasing convenience for both participants and researchers. This can improve participant adherence and reduce dropouts, leading to more complete data sets.
- Real-world data: Wearable devices can capture data in a participant's natural environment outside of a clinical setting. This real-world data can provide valuable insights into how a treatment or intervention performs daily, making the results more applicable and generalizable.
- Reduced burden on participants: Wearable devices can automatically collect data without requiring active input, reducing the burden of manual data entry or frequent visits. This can improve participant experience and compliance.
- Improved data integration: Connected devices can often seamlessly integrate with other digital platforms and electronic health records, facilitating data sharing and analysis across different systems.
- Enhanced safety monitoring: Wearable devices can be programmed to detect and alert researchers or healthcare providers to potential adverse events or safety concerns, enabling timely interventions and closer monitoring of participant well-being.
Connected devices pave a path toward better data
Connected devices are undoubtedly reshaping the landscape of clinical trials, offering a transformative approach to data collection, participant monitoring, and study oversight. By leveraging the power of wearables, sensors, and mobile apps, researchers can access real-time, continuous, and real-world data, enabling them to gain deeper insights into participant behaviors, treatment outcomes, and potential safety concerns.
