Foreign clinical trials need stricter controls, HHS study says

Requiring standardized electronic clinical trial data is among a new report's recommendations.

By Tanya Albert Henry — Posted July 19, 2010

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More than half of clinical trial subjects and sites for drugs and biologics were located outside the United States in fiscal 2008, a new study said. And 80% of the drug and biologic marketing applications that the Food and Drug Administration approved contained foreign clinical trial data.

Western Europe accounted for 58% of subjects enrolled at foreign sites and 60% of the foreign sites. Central and South America had a significant number, including the highest average number of subjects per site compared to other foreign regions, according to a June report by the Dept. of Health and Human Services Office of Inspector General.

The study also found that foreign sites did not have the inspections that domestic ones did. The FDA inspected clinical investigators at less than 0.7% of foreign clinical trial sites compared with 1.9% for domestic sites.

The report comes as critics have raised concerns that foreign trials, particularly those in developing countries, may not provide results generalizable to the U.S. population. Medical ethicists also have questioned whether local regulatory bodies and institutional review boards adequately monitor clinical trials to protect the rights and welfare of subjects and to ensure data integrity.

With reliance on foreign clinical trials expected to grow, the report recommended that the FDA should:

  • Require standardized electronic clinical trial data and create an internal database.
  • Monitor trends in foreign clinical trials not conducted under Investigational New Drug applications and, if necessary, take steps to encourage sponsors to file INDs.
  • Continue to explore ways to expand oversight of foreign clinical trials, including developing inspectional agreements with foreign regulatory bodies, inspecting clinical trials in more countries and looking to implement new oversight models.

Overall, the FDA agreed with the OIG's recommendations.

"For each OIG recommendation, the agency either has ongoing efforts that will address the recommendation or has initiated development of new procedures that will incorporate the recommendation," the FDA wrote in response to a draft of the OIG's report.

The FDA said it has long recognized the importance of data from clinical trials conducted outside the U.S., as long as the studies meet regulatory standards and yield results applicable to American patients. But the agency said increasing clinical trial globalization has presented challenges.

"Resource constraints limit the number of foreign clinical trial site inspections that can be conducted," the FDA said. "In addition, inspections are usually conducted after a clinical trial is completed, too late to fix any problems."

The Assn. of Clinical Research Organizations, which represents companies that focus on clinical research, said in a statement that it supports the recommendations.

Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement, "Is it ethical to conduct such studies outside of the U.S.? In a word: Yes. ... Regardless of the location, however, companies seeking U.S. approval must maintain the FDA's high standards for conducting the trial."

"For instance, any related trials conducted outside the U.S. must comply with FDA requirements covering good clinical practices, in addition to meeting the requirements mandated in these important emerging markets."

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Clinical trials: domestic vs. foreign

In 2008, more than half of clinical trial subjects and sites for drugs and biologics were located outside the U.S. Some say stricter controls are needed on overseas trials to protect subjects and ensure the integrity of the data.

Drugs Biologics
Foreign and domestic subjects 92,859 206,842
Percentage of foreign subjects 56.9% 86.9%
Foreign and domestic trial sites 11,227 717
Percentage of foreign trial sites 54.6% 49.7%

Source: "Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials," Dept. of Health and Human Services Office of Inspector General, June (link)

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