Premier submitted recommendations on ways the Food and Drug Administration (FDA) can reduce barriers to innovation in clinical trials, build resiliency in the drug supply chain and eliminate regulatory gaps and procedural pitfalls at a commensurate pace with evolving artificial intelligence and machine learning technology. The FDA will be considering comments from Premier and other stakeholders during a March 5 public workshop and to inform draft guidance on the use of advanced methodologies in clinical trials for drugs and biological products. In its comments, Premier urged the FDA to:
- Clarify applicability of anti-kickback statute in certain situations that may arise in innovative trial designs and recruitment processes;
- Clearly specify a minimum cybersecurity standard for the transmission and storage of participant health data using digital health technology;
- Issue clear guidance on patient consent and data-sharing requirements in clinical trials, particularly with the rise of promising technology applications for real-world data in decentralized clinical trials and synthetic control arms;
- Take steps to capture, monitor and manage pre-specification activities in drug development; and
- Affirm that Pre-Approval Information Exchange (PIE), which allows trial sponsors to proactively communicate to payors certain information about products in development to expediate coverage upon product approval, is applicable in the case of decentralized clinical trials.