FDA Reaffirms GCP Standards Amid Growing Concerns Over Foreign Clinical Trial Data

A new FDA Voices post authored jointly by senior leaders across four agency centers highlighted the FDA's position on Good Clinical Practice (GCP) compliance. The agency reaffirmed that the standard applies regardless of where a clinical trial is conducted, and it will be enforced.¹

The post was co-authored by the acting directors of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the director of the Center for Devices and Radiological Health (CDRH), and the director of the Oncology Center of Excellence (OCE).

The post identifies three concerns with the growing share of clinical trials conducted outside the United States: that foreign trials may be less generalizable to the American patient population; that Americans lose opportunities to participate in trials of innovative therapies; and that it is more challenging and costly for the FDA to inspect foreign study sites, including through unannounced inspections.

Every FDA regulatory decision depends on the reliability of submitted clinical data, and that standard does not change based on geography. If the FDA is unable to validate that data were collected in accordance with GCP—including at sites where inspection access is constrained or denied—regulations allow the agency to refuse to accept such evidence in support of a marketing application.

Where falsified or otherwise invalid data are identified, the FDA has the authority to eliminate that data from consideration and, if remaining evidence cannot sustain the authorization, deny, withhold, or rescind approval.

"Before the FDA opens the door to let a product reach the American market, sponsors and clinical investigators must open their doors to the FDA," the authors wrote.

Concrete steps the FDA is taking

The post outlines several actions the agency is implementing. The FDA is adding resources for foreign Bioresearch Monitoring (BIMO) inspections, including expanding coverage to more Phase I and early-stage trials and broadening the scope of some inspection assignments to include more trials at a given facility.

The risk-based criteria used to identify sites for inspection are also being updated to better reflect compliance risks in specific countries or regions.

The agency is also moving toward greater transparency when inspection access is denied or conditioned. Sponsors relying on data from such sites are being told to treat that as a material factor in their regulatory strategy, not an administrative footnote.

Additional steps include enhanced reviewer training to identify and escalate data integrity concerns, and more systematic early engagement with sponsors on the provenance and investigational new drug (IND) or investigational device exemption (IDE) status of foreign clinical data.

The FDA specifically flags Phase I studies and Early Feasibility Studies in countries or regions where geopolitical conditions raise concerns about whether informed consent can be freely and voluntarily given. Audits of clinical trial conduct have revealed instances of fabricated participants, falsified health conditions, falsified laboratory results, and concealed adverse events.

A tension sponsors are already navigating

The FDA's latest message arrives at a moment when the globalization of clinical research has been accelerating in part because of the conditions the agency is now responding to. Earlier this year, Applied Clinical Trials caught up with Charlie Paterson, partner at PA Consulting, about how reduced FDA capacity and significant staff turnover in 2025 have reshaped regulatory engagement and operational planning for sponsors.²

Paterson described a dynamic that maps directly onto the FDA's concerns. At the leadership level, the FDA's narrative suggests higher risk tolerance, pointing to expedited timelines, voucher schemes, single pivotal trials, and AI adoption. However, internally, the picture is different.

"Guidance on new approaches isn't forthcoming because divisions may not have the depth of experts needed to engage deeply with innovators," Paterson said in the interview. "That can lead to more conservative guidance and more clinical holds. Globally, that pushes organizations to look to the EMA, MHRA, PMDA, and Health Canada for guidance. Clinical programs are becoming more global, with certain geographies accelerating their ability to host studies—sometimes hosting activity that previously would have launched first in the US."

References

1. Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research. FDA Voice. Current as of September 2, 2026. Accessed September 3, 2026. https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard
2. Evolving FDA Risk Tolerance Reshapes Global Trial Alignment. Applied Clinical Trials. February 6, 2026. Accessed September 3, 2026. https://www.appliedclinicaltrialsonline.com/view/evolving-fda-risk-tolerance-reshapes-global-trial-alignment