FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections. FDA has initiated a public consultation period, seeking feedback on the guidance and how its recommendations should be applied to increasingly diverse trial types and data sources.

The draft guidance integrates the recently updated ICH E6(R3) draft guidelines on GCPs, which were modified to allow for the integration of rapidly developing technological and methodological innovations into clinical trials. FDA notes that the E6(R3) draft guidelines emphasize the use of risk-based and proportionate approaches to data collection, monitoring, and quality management throughout the clinical trial life cycle. The guidelines encourage a focus on data and processes that benefit participant safety and data integrity.

FDA’s draft guidance introduces significant updates around the use of computerized systems in (1) clinical trials, (2) data governance roles and responsibilities for sponsors and investigators, and (3) requirements for obtaining and documenting electronic informed consent.

The guidance includes a section on data governance that provides recommendations on procedures and processes for the use, security, and validation of computerized systems. The section also offers guidance on developing processes to ensure data integrity, traceability, and security throughout the data life cycle by the sponsor, the investigator, or both.

The updated draft guidelines are designed to apply to a wide variety of clinical trials, including those with innovative design elements that can make trials more efficient. For example, the guidelines provide guidance on trials with “decentralized elements,” such as decentralized clinical trials (DCTs) where all trial activities take place at locations other than traditional trial sites. For example, trial-related activities may occur either at the homes of participants or at nearby healthcare facilities for their convenience. The modernized GCPs also encourage the use of appropriate digital health technologies (DHTs), such as wearable sensors, to facilitate agile data collection and patient recruitment.

Key Takeaways

FDA has shown growing interest in modernizing its GCP guidelines to account for emerging technologies. The agency recently released other documents that complement these draft recommendations: in May 2023, FDA released draft guidance on the implementation of DCTs as well as a DHT framework document to guide the use of data from DHTs in regulatory decision-making for drugs and biological products.

FDA’s receptivity to new technologies, acknowledgement of DCT sites, and the outsourcing of clinical trial functions does not indicate that FDA will reduce the need for control over these innovations. Sponsors will have to be equally innovative in developing control mechanisms to ensure continued protection of human subjects and data integrity.

FDA’s focus on DHT and on processes and procedures for promoting data integrity should be considered in light of the agency’s determination to place compliance obligations on a wider range of parties involved in clinical research throughout the trial process, including contractors that provide biostatistical support, data scientists, and data managers. Sponsors, contract research organizations, and third parties will also have to ensure ongoing compliance with FDA’s GCP expectations.

The comment period on the draft guidance will remain open until September 5, 2023.