FDA Framework Will Explore DHTs in Regulatory Decision-Making
The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development.
The agency’s “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” maps a series of activities that will guide its use of DHT-derived data.
“DHTs and DHT-derived data can be important tools in supporting timely access to safe, effective and innovative new medicines for patients,” the agency said in its framework outline.
“Despite the potential advantages of DHTs, many challenges arise when incorporating DHTs and DHT-derived data into regulatory decision-making. This framework outlines a multifaceted approach to collaboratively address these challenges with stakeholders,” the agency said.
Internally, a steering committee of FDA division leaders will guide the framework’s development and activities, ensuring that any policy developed will be consistent across the agency. The committee will convene a series of public meetings with stakeholders, including patients, biopharmaceutical companies, DHT companies and academia, gathering input on relevant issues.
The framework will also seek demonstration projects that might help inform the best ways to integrate DHT-derived data into regulatory decision-making. Guidance may arise from these projects.
The FDA recognizes, however, that considerable information technology updates will be needed to handle the new data sources. These will likely include updates supporting the review of DHT datasets and DHT-related submissions, training staff to evaluate these data and developing new statistical methodologies.
DHT-derived data will be stored on a secure cloud server, the agency said. After establishing the cloud environment, the agency will pilot a secure, cloud-based mechanism to support submission and review of DHT-generated datasets.
Externally, the FDA will be meeting with sponsors, patient advocacy groups, DHT companies, clinical investigators, international regulatory bodies and professional societies.
“Such activities can help FDA better understand the challenges and opportunities associated with DHTs and will include holding public meetings, running demonstration projects and publishing guidance on the use of DHTs to support drug development and review.
Although the framework itself is not a guidance, the agency has published several draft guidances dealing with the topics it explores and plans to release more later this year. The most recent of these, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” was released earlier this month (CenterWatch Weekly, March 20).
Upcoming guidances include “Decentralized Clinical Trials for Drugs, Biological Products, and Devices,” and “Regulatory Considerations for Prescription Drug Use-Related Software.”
The agency invites comments on the guidance by May 23.
Read about the framework here: https://bit.ly/3JDJOQQ.