Digital health technologies: efficient use for modern clinical trials

The integration of digital health technologies (DHTs) into clinical trials is changing the way medical studies are conducted.

These technologies, which are based on platforms, software, sensors and connectivity, enable more accurate and efficient data collection and open up new opportunities for decentralised and patient-centered studies. The Food and Drug Administration (FDA) has taken on a central role in promoting and regulating the use of DHTs in drug development and provides a framework and practical guidance for their integration in its statement from August 2024.

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Benefits of digital health technologies in research

DHTs allow real-time data to be collected directly from the living environment of study participants. This reduces the workload for patients, improves the diversity of participant groups and enables the integration of populations that are traditionally difficult to access. The technologies range from portable sensors to apps or scales connected to the Internet to objectify measurement variables that can securely store and analyze data.

FDA is stressing the importance of these technologies for modernising clinical trials. It has launched initiatives to promote their use, including a steering committee for strategic direction and demonstration projects to validate DHTs. These measures aim to improve the quality and efficiency of clinical trials while meeting regulatory requirements.

Implementation challenges

However, the use of DHTs also poses challenges. This includes ensuring data integrity, validating the technologies used, and compliance with strict data protection and security requirements. The FDA provides specific guidelines to ensure that DHTs function reliably and meet regulatory standards. Another important aspect is documenting device performance. This is crucial for approval by authorities such as the FDA and requires careful planning and execution throughout the research process.

Prospects for decentralised studies

The trend towards decentralised clinical trials is significantly driven by DHTs. These approaches enable patient-centered data collection, which no longer requires participants to physically appear at study sites. This promotes a realistic evaluation of therapies and at the same time increases the reach of clinical trials.

The use of digital technologies also offers an opportunity to expand access to high-quality studies. This is particularly relevant in geographically remote regions, for patients with reduced mobility or for better integration of a clinical trial into everyday (professional) life.

Digital health technologies are an integral innovative part of modern clinical trials and research. They offer innovative solutions to many challenges of traditional study approaches and open up new opportunities for more efficient data collection and analysis. At the same time, these technologies require careful planning and validation to take full advantage of their benefits. FDA's active support for this change through clear frameworks and practical guidelines is welcome.

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Source: https://www.fda. gov/science -research/science-and research-special-topics/digital-health-technologies-dhts-drug-development (please delete spaces for link)