Digital Health Technologies (DHTs) use in clinical research is no longer a futuristic concept—it’s quickly becoming the norm. Recognizing this shift, the FDA issued comprehensive guidance in 2023 on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This guidance sets critical standards for validating, deploying, and monitoring these tools in clinical trials. The guidance stresses the importance of reliability, data quality, patient safety, and privacy—key factors as trials become more decentralized and reliant on technology.
What Are Digital Health Technologies?
According to the FDA, Digital Health Technologies encompass many tools designed to collect health data remotely. These include wearables, sensors, mobile applications, and software transmitting health-related data in real time. The goal of the FDA’s guidance here is to clarify what qualifies as a DHT and, more importantly, to establish how these technologies can contribute to clinical trials.
The FDA recognizes that data collected in traditional clinical settings can be limited. In-person visits provide only a snapshot of a patient’s condition, often missing the broader picture of their daily health patterns. This is where DHTs, like Aktiia’s continuous BP monitoring bracelet, come in. By enabling constant, real-world monitoring, Digital Health Technologies allow researchers to gather data on how a patient’s health fluctuates in their natural environment. This continuous data provides richer insights into conditions that require hypertension management, such as cardiovascular disease, diabetes, and chronic kidney disease, which often benefit from precise, long-term blood pressure tracking to inform clinical outcomes better.
The FDA emphasizes DHTs because they offer a more holistic view of patient health, moving beyond the confines of the clinic. However, with this new capability comes the responsibility to ensure that the data collected remotely is just as reliable and accurate as that collected in a controlled environment.
Key Considerations for Selecting DHTs in Clinical Trials
A significant point of emphasis in the FDA’s guidance is the concept of fit-for-purpose—ensuring that the selected DHTs are appropriate for the specific trial’s objectives and the patient population involved. The FDA doesn’t just want sponsors to use technology for technology’s sake; it wants to ensure that these tools effectively serve the trial’s intended goals.
The term “fit-for-purpose” is central to the FDA’s guidance, and it essentially means that a DHT should be appropriately validated and capable of addressing the specific objectives of a clinical trial. The technology must be well-suited for the patient population, the studied condition, and the data required for meaningful analysis. When the FDA urges sponsors to consider whether a DHT is “fit-for-purpose,” it’s pushing for a thoughtful selection process. This involves ensuring that the chosen technology can reliably collect data relevant to the trial’s endpoints, functions appropriately in the intended setting, and fits within the broader clinical context. Validation for the specific population also ensures that the DHT can accurately measure the health outcomes of interest.
However, in trials focused on mental health or sleep disorders, where different metrics are crucial (e.g., brain activity or sleep patterns), a DHT designed for cardiovascular monitoring wouldn’t be fit for purpose unless adapted to the specific needs of those studies. A specific device (pulse-oximeter, continuous glucose monitor CGM} would have to be tested to meet ISO 15197:2013. while a pulse oximeter must meet ISO 80601-2-61:2017
As the FDA opens the door to more remote data collection, the agency remains aware of the risks associated with collecting data outside controlled environments where inconsistencies or errors could arise. Aktiia, however, has undergone rigorous testing and validation to meet these stringent requirements. Its blood pressure monitoring technology has been proven to track blood pressure accurately across different patient demographics, environmental conditions, and health statuses. This includes testing in real-world scenarios where patients may have comorbid conditions or varying physical states, such as during physical activity or periods of rest. Aktiia’s system still reliably collects accurate blood pressure measurements under these varied conditions.
Furthermore, the FDA emphasizes that trial endpoints must be directly tied to the data collected, and data integrity is paramount. In the case of Aktiia’s device, the company has implemented robust mechanisms to reduce noise and ensure the clarity of the data it collects. Aktiia’s technology effectively filters out potential data inconsistencies—such as those caused by patient movement or environmental factors—so that the blood pressure readings are accurate and precise.
Future Implications of the Guidance
Finally, the FDA’s guidance on Digital Health Technologies points to a future where clinical trials are increasingly decentralized and patient-centered. The agency sees DHTs as a way to make clinical trials more inclusive and reflective of real-world conditions. Trials that rely solely on clinic-based visits may exclude certain populations or fail to capture how treatments work in everyday life. By encouraging the use of Digital Health Technologies, the FDA is promoting a model of clinical research that is more flexible, accessible, and capable of capturing richer data and more reflective of patient experiences. The FDA’s forward-looking guidance sets the stage for a future where real-world evidence plays a more significant role in clinical research, ultimately speeding up drug development and improving patient outcomes.
Today's technology only allows for continuous monitoring of BP, glucose, and Oxygen saturation. Other devices will come to market to measure electrolytes and blood chemistry.
The FDA’s 2023 guidance on Digital Health Technologies for Remote Data Acquisition offers a comprehensive roadmap for integrating cutting-edge tools into clinical research. By focusing on validation, data integrity, risk management, and regulatory compliance, the FDA ensures that DHTs can enhance trial quality without sacrificing patient safety or data reliability. This guidance supports the safe and effective use of DHTs and pushes the boundaries of clinical research toward a more decentralized and patient-focused future, where real-time data offers deeper insights into how treatments impact lives.
Unpacking FDA Guidance on Digital Health Technologies in Clinical Trials
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