01/25/2022
Photo by Luke Chesser on Unsplash
The US Food and Drug Administration (FDA) released a draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” for public comment in December 2021. The draft guidance provides best practices for how digital health technologies (DHT) can be used to collect and support endpoint data and what information is needed in an investigational new drug application (IND) or an investigational device exemption (IDE) application that uses DHT. DHT is a “system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.”
Background
Even before the pandemic, decentralized clinical trials began to evolve. These involve reducing the number of times study participants return to the site for study visits, thus increasing compliance and reducing burden to participants. Home health, local doctors, labs, and imaging are used a greater frequency. Wearable devices, apps for participants’ phones, and other electronic data systems collect trial data and send it to the site. During the pandemic, remote participation and remote monitoring frequency rose to unprecedented levels, demonstrating the feasibility of remote data collection to continue and expand in the coming years.
Draft Guidance Summary
The recommendations focus on:
Selection of DHTs that can be used in a trial
Verification and validation of DHTs
Identification of risks to using DHTs
Management of the identified risks
DHTs used in trials can:
Record data directly from participants
Use sensors to record physical or behavioral data, such as blood pressure
Include electronic clinical outcome assessments (eCOA) or electronic performance outcome (ePRO)
Be made of hardware and software combinations
Be used together to collect data for multiple purposes
Appendix A in the draft guidance lists examples of DHT that can be used in a trial.
Sponsor Recommendations
Recommendations for sponsors include that the DHT is fit-for-purpose, in this case meaning that the validation supports the use in a trial and that the resulting data will be reliable. When selecting the DHT, there should be a clear, documented rationale for its use given the selected population, the specifications of the DHT, and consideration of if the participant’s DHT should be used. Data should be protected from unauthorized access.
Additionally, sponsors need to consider recommendations for the following:
Description of the DHT in a regulatory submission
Verification, validation, and usability of DHT used in trials
Evaluation of clinical endpoints from DHT data
DHTs in the statistical analysis plan
Risk considerations with use of DHT
Protection and retention of DHT records
To ensure participant protection and quality data, recommendations for sponsors using DHT include:
Ensure site staff are trained on appropriate use of DHTs and data collection responsibilities and include the training materials in the regulatory submission.
Develop a technical assistance plan for participants or site staff.
Develop a risk management plan that includes potential problems participants may face.
Develop a safety monitoring plan to address measurements obtained through DHT that may impact a participant’s health, such as hypoglycemia.
Create contingency plans for updates or changes to DHT, with documentation of any changes.
Put into place procedures to identify and address DHT errors, platform errors, and lost or damaged DHTs, including alternate data collection plans.
Some DHTs are considered medical devices, so it is important to check the regulatory status of the DHT planned to be used in a trial. It is recommended to engage with the FDA during planning to discuss using DHT in a clinical trial.
Site Recommendations
Clinical sites need to ensure that participants are informed what data will be collected by DHT, how their privacy and the security of the data will be protected, and if there will be any third party access to the data. Participants should be trained on proper use of DHT per the protocol. If the protocol specifies, data from DHT should be periodically reviewed.
Comment on the draft guidance through March 22, 2022 HERE.
The FDA is holding a webinar on the draft guidance February 10th at 1:00 PM - 2:30 PM EST. Register HERE.
- The Clinical Pathways Team
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