There is no place like home for clinical research
Foreign IRBs lack experience, monitor trials less
Clinical trials in foreign countries do not protect their patient participants as adequately as safeguards in place for domestic clinical trials. That’s the conclusion from a new report released by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). Inspector General Janet Rehnquist and staff suggest that the U.S. Food and Drug Administration (FDA) take a more aggressive approach at protecting human subjects enrolled in clinical trials in foreign lands, just as it does in its home nation. The report, titled The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (OEI-01-00-00190) was published in late September 2001.
Foreign clinical trials do have domestic ramifications because pharmaceutical companies submit trial data to the FDA from those trials when applying for a new drug application (NDA). But more often than not, the FDA cannot determine how the initial trial data were gathered when from a foreign country. Perhaps more troubling from the report is the finding that foreign investigators often do not submit along with the NDA a signed attestation form stating they are responsible and accountable for ethical research. (See box, below.)
| The Attestation
The Food and Drug Administration requires that clinical investigators working under an investigational new drug sign an attestation. The following list of commitments must included in the signed document:
Source: FDA form 1572. |
Here are the findings from the OIG report:
- The FDA oversees significantly more foreign research than it did 10 years ago.
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Source: U.S. Department of Health and Human Services’ Office of Inspector General. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Washington, DC; 2001.
- Sponsors are expanding research sites into countries that appear to have limited experience with clinical trials.
- The FDA cannot assure the same level of protection for human subjects in foreign trials as it does for domestic trials.
- Organizations studying foreign trials have raised concerns about foreign IRBs.
OIG recommendations include the following:
- Obtain more information about the performance of foreign IRBs.
- Help foreign IRBs build capacity.
- Encourage sponsors to obtain ethical adherence from foreign investigators.
- Encourage greater sponsor monitoring.
- Develop a database to track the growth and location of foreign research.
Recommendations specifically for the OHRP include:
- Exert leadership.
- Encourage accreditation.
Concern is growing
Organizations that work with foreign IRBs have expressed concern over the experience of committee members and the ethics of board actions. The National Bioethics Advisory Commission, for example, found IRB problems fairly common among developing countries. The report Attitudes and Experiences of U.S. and Developing Country Investigators Regarding U.S. Human Subjects Regulations includes results from an international survey.
Clinical investigators who conducted research in Africa, Asia and Latin America were questioned. Among the results:
- Some IRBs were improperly trained.
- Many IRBs were conducting scientific and budgetary reviews rather than ethical reviews.
- Most IRBs were not properly monitoring research.
Additionally, the Geneva-based World Health Organization conducted seminars in 1999 among countries in Asia, Africa, and the western Pacific. The agency discovered several weaknesses (see box, below). As a result of the seminars, the World Health Organization developed a set of guidelines titled Operational Guidelines for Ethics Committees that Review Biomedical Research.
Weaknesses in Asia, Western Pacific, and Africa
Source: World Health Organization, Geneva |
The OIG identified 19 countries that have experienced an FDA inspection in a three-year period.
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[Editor’s note: For copies of the OIG report The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects, contact the Office of Evaluation and Inspections, Boston Regional Office. Telephone: (617) 565-1050. World Wide Web: http://oig.hhs.gov/oei.]
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