Digital health technologies (DHTs) have the potential to bring numerous benefits to the creation of medical products, such as drugs.
The evolution of DHTs, including electronic sensors, computing platforms, and information technology, opens up fresh avenues to gather clinical trial data directly from patients.
The emergence of portable DHTs that can be worn, implanted, ingested, or placed in the environment enables the real-time collection of data from trial participants in their residences or other locations that are distant from clinical trial sites.
DHTs encompass various technologies, including wearable, implantable, ingestible, and environmental sensors, as well as software applications on mobile phones, among others.
The development of sensor technology, general-purpose computing platforms, and methods for data capture, transmission, and storage has transformed the ability to obtain and analyze clinically relevant information from individuals remotely.
DHTs that are utilized for remote data collection are increasingly prevalent in healthcare and offer significant prospects in clinical research.
These technologies can support conventional site-based clinical trials and facilitate the execution of DCTs, which are clinical investigations where some or all trial-related activities occur at locations other than traditional clinical trial sites.
Moreover, DHT software can also be distributed for use with a prescription drug.
Some of the potential benefits of DHTs are:
· The capability to make constant or frequent measurements of clinical characteristics
· The ability to capture novel clinical features that might not be obtainable during conventional study visits
· The decentralization of clinical trial operations by gathering clinical data from study participants in remote locations
To facilitate the appropriate use of DHTs in drug development, FDA has published draft guidances that, when finalized, will reflect FDA’s current thinking on a number of DHT topics, and the Agency plans to develop additional guidance documents.
Draft guidance for industry, investigators, and other stakeholders Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (December 2021)
This draft guidance outlines proposed recommendations intended to facilitate the use of DHTs in clinical investigations, as appropriate, for the evaluation of medical products.
Draft guidance for industry Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023)
The draft guidance addresses commonly asked questions about the applicability of part 11 to electronic records, electronic signatures, and electronic systems used in clinical investigations, including use of DHT-derived data.
Draft guidance for industry, investigators, and other stakeholders Decentralized Clinical Trials for Drugs, Biological Products, and Devices (May 2023)
This guidance provides recommendations to clarify and advance the use of decentralized clinical trials to support the development of drugs and devices.
Draft guidance for industry Regulatory Considerations for Prescription Drug Use-Related Software (targeted for publication by end of fiscal year 2023 per commitment letter)
This draft guidance will cover how such software may be described in labeling, including in the Prescribing Information, when the software is distributed with a drug or integrated as part of a drug- or biologic-led combination product, as well as when the software is distributed by an applicant independent of an approved product.
