Clinical research has historically been anchored to physical locations, requiring participants to travel to specific sites for assessments. A digital health clinical trial shifts from this model by integrating technology to interact with participants and gather information remotely. This approach allows aspects of a study, from data collection to communication, to occur outside a traditional clinic. This results in a more flexible research method that adapts to a participant’s real-world environment.
Core Technologies in Digital Trials
Wearable devices and biosensors are a primary component of the digital trial model. Technologies like smartwatches, fitness trackers, and continuous glucose monitors collect physiological data without a clinic visit. These devices can track metrics that provide a constant stream of information, including:
- Heart rate
- Blood pressure
- Sleep patterns
- Activity levels
In some cases, smart clothing or skin patches can monitor more specific measurements, offering a detailed view of a participant’s health in their natural setting.
Mobile health (mHealth) applications on smartphones and tablets serve as a central hub for participant interaction. These apps are used for a wide range of functions, such as:
- Collecting electronic patient-reported outcomes (ePROs), where participants log symptoms or quality of life information
- Facilitating electronic diaries (eDiaries)
- Delivering medication reminders to improve adherence
- Providing a secure channel for trial-related communications
Telehealth platforms use video conferencing and secure messaging to conduct remote check-ins and consultations. This technology reduces or eliminates the need for many physical site visits, connecting participants with investigators from their homes. Telehealth makes trial participation more convenient and less disruptive to a person’s daily life.
A growing category of tools is Digital Therapeutics (DTx), which are software-based interventions designed to treat, manage, or prevent a disorder. Unlike apps that simply monitor health, DTx deliver clinical-grade therapeutic interventions. In a clinical trial, the DTx product is often the subject of the investigation. Researchers use these trials to measure the efficacy and safety of the software as a medical intervention.
How Digital Tools Reshape Trial Design
The integration of digital technologies is altering the architecture of clinical studies, leading to new operational models. One model is the Decentralized Clinical Trial (DCT), where most or all trial activities occur remotely. A more common approach is the hybrid model, which blends remote data collection with in-person site visits for procedures that cannot be done remotely. This flexibility allows trial designs to be more patient-centric and efficient.
Digital tools enable a shift from episodic to continuous data collection. Traditional trials capture data during scheduled clinic visits, providing only snapshots in time. Digital tools like wearables allow for collecting data streams 24/7, revealing trends and variability that would otherwise be missed. For instance, monitoring a patient’s scratching habits at home with a wearable can provide more realistic insights than a verbal report during a clinic visit. This high-frequency data can lead to a better understanding of a disease and an intervention’s effects.
Digital tools also transform how participants are recruited and enrolled. Traditional recruitment relies on finding individuals near a research site. Digital recruitment uses online platforms, social media, and electronic health record databases to reach potential participants over a much larger geographic area. This approach can accelerate enrollment timelines by reaching a wider pool of candidates.
The Patient Experience in a Digital Trial
For participants, a primary benefit of a digital trial is the reduction in travel burdens. Traditional trial participation often requires taking time off work, arranging childcare, and covering transportation costs. By bringing the trial to the patient’s home, these logistical and financial barriers are lowered. This makes participation feasible for a wider range of people, including those with mobility issues, rare diseases, or demanding schedules.
This increased accessibility opens clinical research to a more diverse population. Individuals who were previously excluded by geography, such as those in rural areas, can now participate in research from home. Including a more geographically and demographically representative population improves equity and enhances the generalizability of trial results. This convenience is a factor in improving both recruitment and retention rates.
Digital trials can also increase participant engagement. User-friendly mobile apps and devices allow patients to see their own health data in real time, transforming them from passive subjects into active data contributors. This can improve adherence to trial protocols, as participants can communicate more easily with the research team through integrated messaging and telehealth features.
Data Integrity and Regulatory Oversight
Ensuring the quality and validity of data collected from digital tools is a main focus. Data from consumer-grade wearables may not have the same accuracy as medical-grade devices. Research sponsors must implement validation protocols to confirm that the technology is reliable for regulatory submission. This involves establishing that the digital measurements are accurate, consistent, and measure what they claim to measure, a process that is a focus for regulatory bodies.
Protecting the privacy and security of health information is a high priority. The transmission and storage of data must comply with regulations like the Health Insurance Portability and Accountability Act (HIPAA) in the United States. This requires security measures like end-to-end encryption for data in transit and secure cloud environments for data at rest. All technology platforms must be vetted for security risks to prevent data breaches.
The reliance on technology introduces the “digital divide,” which can impact equity. Requiring a smartphone, reliable internet, or digital literacy can exclude older or lower-income populations. To mitigate this, trials may provide participants with the necessary devices, training, and technical support to ensure they can use the tools effectively and help maintain a diverse trial population.
Regulatory agencies like the U.S. Food and Drug Administration (FDA) are adapting to these changes. The FDA has issued guidance for decentralized trials, outlining expectations for design, data integrity, and patient safety. This framework clarifies how regulations apply to digital settings and helps ensure data meets the standards for evaluating new medical products. This evolving regulatory landscape helps standardize practices and build confidence in using digital health technologies in research.