Special thanks to Morrison & Foerster Regulatory Analyst Brandy Guarda for contributing to this article.
In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while mitigating health risks. During the public health emergency, clinical trials have run into challenges ranging from quarantines to site closures, travel limitations, supply chain interruptions, and possible infection by either the site personnel or trial participants.[1] Throughout the pandemic, FDA has recognized that it may need to make modifications to protocol-specified procedures; and digital health technologies (DHTs) came to the rescue in clinical trials, assisting with remote data acquisition.
On February 10, 2022, FDA held a webinar to discuss its draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.[2] Presenters at this event included Leonard Sacks, MD (Center for Drug Evaluation and Research (CDER)), Elizabeth Kunkoski, MS (CDER), Matthew Diamond, MD, PhD (Center for Devices and Radiological Health (CDRH)), Christina Webber, PhD (CDRH), and Anindita Saha (CDRH).[3]
Anindita Saha (CDRH) provided a few clinical scenarios to pull together the presented concepts and overarching objectives:
- DHTs have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals.
- Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection.
- DHTs provide opportunities to record data directly from trial participants (e.g., performance of activities of daily living and sleep) wherever the participants may be (e.g., home, school, work, or outdoors).
- Some DHTs may also facilitate the direct collection of information from participants who are unable to report their experiences (e.g., infants or cognitively impaired individuals).
As far as the rest of the program, Leonard Sacks, MD (CDER) introduced the definitions of patient-generated health data (PGHD) and DHTs. He discussed the benefits of using DHTs in a clinical investigation: (1) to obtain continuous measurements, (2) to document rare events, (3) to obtain real-world data from patients, and (4) to increase convenience of remote participation in trials. DHTs can also assist with obtaining correct measurements, finding suitable metrics, enhancing the ability to interpret continuous data, and ensuring proper use by patients.
Matthew Diamond, MD, PhD (CDRH) discussed the regulatory considerations of DHTs and introduced the concept of a sponsor needing to find a DHT to be “fit for purpose.” FDA recommends the use of third-party verification to determine whether a DHT is fit for purpose and that sponsors engage frequently and early with the agency to discuss any use of a DHT in a specific clinical trial. Elizabeth Kunkoski, MS (CDER) further expanded on the concept of fit for purpose, while providing guidance on how to select DHTs for a clinical investigation. Fit-for-purpose considerations include DHT design and operation, ability to measure clinical events, and usability. The sponsor must also verify and validate the DHT to ensure that it is fit for purpose. In terms of regulation by FDA, those DHTs that meet the classification of a medical device are generally exempt from premarket clearance or approval when they are intended for use in clinical trials.
As far as communication with FDA regarding a DHT, the agency guidance documents on formal meetings, voluntary qualification programs (e.g., DDT, MMDT, and ISTAND), and CDRH’s Digital Health Center of Excellence (DHCoE) were suggested as additional support for sponsors considering the use of DHTs in a clinical trial. If a DHT has qualified for a specific context of use it may be used in multiple clinical trials.
Furthermore, Elizabeth Kunkoski, MS (CDER) recommended that data from DHTs be treated as any other endpoint development (e.g., definition, justification, type, and positioning). FDA highlighted two types of risks with DHTs: clinical security risks (e.g., cybersecurity/hacking) and privacy-related risks to the data collected on the DHT (e.g., end-user agreements/terms of service). She also recommended a review of the guidance on record protection and retention.
If you have any questions regarding the use of DHTs in a clinical trial, please contact a member of our FDA Regulatory Compliance team.
[1] FDA Final Guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (Aug. 2021), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency.
[2] FDA Draft Guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Jan. 2022), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations.
[3] FDA Webinar Slides, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Feb. 10, 2022), available at https://sbiaevents.com/files2022/DHTs-Webinar-2022-02-10.pdf.