Final FDA Guidance Document on Digital Health Technologies for Data Collection in Clinical Trials

On December 21, 2023, the US Food and Drug Administration (FDA) published a final guidance document that addresses the use of digital health technologies (DHTs) for data collection in clinical trials. This document represents an evolution of the original 2021 draft and provides detailed recommendations for the use of DHTs in various phases of drug and medical product development. It is an important step to promote the integration of modern technologies into clinical research while meeting regulatory requirements.

Definition and significance of digital health technologies

Digital health technologies are defined by the FDA as systems that use computer platforms, connectivity, software, and/or sensors to collect data for healthcare.

Their application in clinical trials opens up new opportunities for data collection, enables wider participation in studies and supports decentralized research approaches. Especially during the COVID-19 pandemic, it became apparent how important these technologies are for modernising clinical trials.

Scope of the guide document

The final guidance document covers a variety of aspects, including the selection of suitable DHTs, their verification and validation, data storage, and risk management. It also includes recommendations on how to describe the technologies as part of submissions to the FDA and on the role of sponsors and reviewers in the use of DHTs. However, the document does not address the question of whether a digital technology should be classified as a regulated device or specific requirements for clinical outcome assessments (COAs).

Important changes

Compared to the original draft from 2021, several significant additions and clarifications have been made:

• Expanded definition: The description of DHTs was clarified, making it clear that their function is critical.
• Scope of application: The scope of the guide document was extended to include Drug/Device Development Tool (DDT/MDDT) submissions.
• Use within and outside clinic visits: The document now explicitly takes into account the use of DHTs both during visits to clinical facilities and when collecting data outside such visits.
• Regulatory Interaction: Clarifications were made regarding the submission of IND (Investigational New Drug Application) versus IDE (Investigational Device Exemption).
• Technical specifications: A new section is dedicated to technical and performance specifications (“fit-for-purpose”) to ensure that DHTs are suitable for their intended purpose.
• Bring Your Own Device (BYOD): The BYOD approach section has been streamlined.
• Verification and Validation: Additional recommendations have been included on the consistency of different DHT products and differences between remote data collection and data collection in clinical settings.
• Statistical analysis: The section on statistical analysis and study design considerations has been expanded.
• FDA inspection approach: Clarifications have been made about how FDA conducts data inspections.
• End of study process: New guidelines for graduation procedures after the end of studies have been introduced.
• Role of reviewers: It was clarified that auditors are not required to continuously monitor data unless clinically necessary. At the same time, their role in training study participants is emphasized.

Future developments

The FDA is planning further workshops on digital health technologies to clarify open questions and promote dialogue with stakeholders. In addition, a newly established DHT Advisory Committee will help to further develop policy strategies and promote the use of these technologies in clinical research.

Conclusion

The final FDA guidance document provides a comprehensive framework for the use of digital health technologies in clinical trials. It takes into account both technical and regulatory aspects and aims to promote innovation without sacrificing the security and reliability of the data collected. With this move, FDA underscores its commitment to actively support the modernization of clinical trials while providing clear guidelines for using these technologies.

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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)

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