Drugs

Foreign Clinical Trial Data and Raising Risks for Sponsors

FDA is ramping up oversight of clinical trials conducted outside the U.S., placing greater emphasis on data integrity, GMP compliance and the applicability of foreign study results to American patients, according to an analysis by attorneys at Foley Hoag LLP.

In a 10/16 client alert, attorneys Matthew Piscitelli and Bryant Godfrey said sponsors relying on overseas studies to support INDs or marketing approvals face heightened regulatory risks as the agency expands oversight of foreign research sites.

They note thatunder 21 CFR 312.120, foreign studies not conducted under an IND must comply with GCP requirements, including independent ethics committee review, informed consent and the ability of FDA inspectors to validate study data. Sponsors must also document investigator qualifications, research facilities and monitoring procedures.

Data integrity is another growing concern, particularly at foreign sites where FDA inspection resources are limited. The agency has identified risks involving inadequate monitoring, deficient source documentation and potential data falsification.

FDA officials recently outlined plans to strengthen bioresearch monitoring inspections, improve reviewer training and increase scrutiny of studies conducted outside the IND framework.

“In light of regulatory, demographic, and data integrity concerns, sponsors contemplating foreign clinical development programs must undertake rigorous upfront planning and risk mitigation,” they wrote. “Sponsors should engage with FDA early through pre-IND or pre-NDA meetings to discuss expectations for foreign data, particularly where approval or subsequent trials may be sought based solely or primarily on foreign clinical evidence. Site selection diligence, monitoring plans, and thorough investigator training programs are essential to demonstrate compliance with GCP and to satisfy regulatory requirements as a product’s clinical program progresses.”

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