Clinical Trials Go Global

Additionally, the report pointed to subcontracting by CROs, which “fragments clinical trial-related tasks further and squeezes budgets even more. Cost and time pressures combined with the fragmentation of clinical trials can easily lead to a lack of oversight over and comprehension of the full trial process.”

Who Is Responsible for Oversight?

If a drug is intended for the U.S. market, it must be approved by the FDA. Studies conducted under an Investigational New Drug (IND) designation are governed by FDA informed consent and Institutional Review Board requirements, while those foreign studies not conducted under an IND are governed by another rule.^9,10 The FDA has never had the resources to adequately police global and U.S. sites.

In its 2010 report, the HHS Office of Inspector General said the FDA inspected only 1.9% domestic clinical sites and 0.7% of foreign trial sites. The report noted that “logistical challenges and sponsors’ submission of clinical data in a nonstandard format also hinder FDA’s ability to monitor foreign clinical trials. FDA was also unable to account for all clinical trial information because application files were missing or the sponsors failed to provide site locations and subject enrollment in the clinical study reports.”

In the report, the HHS suggested that the FDA adopt and require standardized electronic clinical trial data and an internal database, monitor foreign clinical trials not conducted under INDs, and continue to explore ways to expand its oversight of foreign clinical trials.

At least 80% of approved marketing applications for drugs and biologics contain data from foreign clinical trials.

Oversight Is Evolving

According to Karen R. Mohoney, FDA spokesperson, inspections of clinical trials outside the United States have steadily increased, from 32 in FY 2003 to 112 in FY 2010. “We expect that trend to continue,” she says. In the past few years, the FDA has opened offices in China, India, Latin America, the Middle East, and South Africa. She says that “these offices were strategically chosen based on problems in the past and on the ability to leverage expertise and to build on past experiences. These offices were established following a special congressional appropriation in 2008.”

The FDA’s Center for Drug Evaluation and Research is currently developing a risk-based site selection computerized model to help choose sites for inspection. Additionally, there are efforts underway to assist in standardizing the way that data are collected and submitted to the FDA, Mohoney says. The FDA is conducting training activities in good clinical practice in research outside the United States and is collaborating with the European Medicine Agency to conduct joint inspections and share information on applications, inspections, and best practices.