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US: FDA outlines plan for digital health technologies for clinical trials

2023/03/28  US FDA

The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the Food and Drug Administration (FDA), regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. Among other activities relating to the use of DHTs, under section IV.C.1 of the commitment letter, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter “Framework”).

This document outlines the Framework that FDA will use to implement a multifaceted DHT program for drugs. The DHT program will include workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. This document is not a guidance document and does not propose or establish policies.

The Framework includes the following activities outlined in the PDUFA VII commitment letter:

  • Establishing a steering committee, including members from the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Oncology Center of Excellence (OCE), the Office of the Commissioner, and the Center for Devices and Radiological Health (CDRH) and its Digital Health Center of Excellence (DHCoE), to ensure consistent policy across FDA regarding the use of DHT-derived data in regulatory decision-making for drugs
  • Convening public meetings or workshops with key stakeholders, including patients, biopharmaceutical companies, DHT companies, and academia, to gather input into issues related to the use of DHTs in regulatory decision-making
  • Identifying demonstration projects to inform methodologies for efficient DHT evaluation
  • Publishing guidance documents for drugs on the use of DHTs in traditional and decentralized clinical trials (DCTs) and in other areas as identified through stakeholder engagement
  • Publishing guidance on regulatory considerations for prescription drug use-related software that includes information about software that is disseminated by a drug applicant for use with a prescription drug or biologic product that may be described in labeling, including prescribing information
  • Enhancing consistency across centers with regards to the development, use, and review of DHTs and associated endpoints through building technical expertise and review capacity, providing staff training in evaluation of DHTs, and developing statistical methodology regarding DHT-derived clinical endpoints
  • Enhancing IT capabilities to support the review of DHT-generated data

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