GxP Perspectives

19 February 2009 Page B7: The New York Times misses the point on international research. Times reporter Natasha Singer uses a study published in the New England Journal of Medicine by Duke researchers led by Dr. Kevin A. Schulman, a professor of medicine at the Fuqua School of Business at Duke, to raise question regarding the validity of research conducted outside the United States. (See Blogroll on right for link to article.)

My own experience, unlike Ms. Singer or Dr. Schulman, is to actually go to clinical sites and conduct GCP audits of the research. Things look differently when you are at the research sites. I have audited studies in Beirut, Taipei, and St. Petersburg (Russia, not Florida) and found them to be conducted in an exemplary fashion. On the other hand, I have seen horrible research in Sacramento, Ft. Worth, and St. Petersburg (Florida, not Russia).

Let’s look at a few of the problems with the Duke study. First, they assume that there is some form of inherent difference between Americans and everyone else. This conveniently ignores the point that Americans are composed of everyone else. I once audited a study by an American researcher in Los Angeles. The study had difficulties with the number of subjects who were lost to follow-up. Why? Immigration authorities had deported them to Mexico and Central America.

Ms. Singer “balances” her article by citing a study by Tufts University that sees things a little differently. However, these academic studies look at numbers and don’t really give us a qualitative analysis. What about the quality of research? In many countries the study coordinators are first or second year residents with the letters “MD” after their names. By contrast, in the United States many study coordinators are unlicensed medical assistants who perform protocol-required activities including screening for eligibility and eliciting adverse events. You tell me who is more qualified. FDA is so concerned about unqualified study staff that they published the draft guidance document, “Supervisory Responsibilities of Investigators,” which you can find listed on the Blogroll on the right.

Clinical trials are a globalized industry. International trials are a reality and a good reality at that. What we need are clear international standards to govern the trials. And we need international cooperation in monitoring and auditing the trials. The obvious place to start is with the International Conference on Harmonization (ICH) and the Declaration of Helsinki. These are standards recognized by just about everybody except, at times, the FDA.

The recent Final Rule changing 21 CFR 312.120 is not helpful in these harmonization efforts. It severs FDA’s relationship with the Declaration of Helsinki in favor of “Good Clinical Practice.” This ignores the fact that in the introduction to ICH E6, the combined GCP guidance document published in the Federal Register (1996), specifically describes Good Clinical Practice in part:

“recording and reporting trials that involve the Compliance with this standard (GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”

Ms. Singer and the Duke University researchers would be more helpful if they told us the quality of international research and the status of international research standards. Merely lamenting the lack of U.S. based trials is not helpful.

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