Outsourcing of Pharma Clinical Trials

Posted on February 20, 2009
Filed Under International, Pharmaceuticals, Regulatory |

The New York Times writes about the so-called “outsourcing” of drug clinical trials. The Times relies on an article appearing in The New England Journal of Medicine.  Specifically, the researchers suggest “an ethical quagmire when drugs intended for wealthy nations are tested on people in developing countries. The authors suggest that human volunteers in foreign countries may be unduly influenced with the promise of financial compensation or free medical care to participate in clinical trials.”

The authors also question whether the results of trials in developing countries may be directly translated to American (or, presumably, Western) patients.

The article’s authors have their critics.  Some claim the authors used too simplistic data mining to raise an alarm and lack (or have not presented) hard evidence of widespread ethical or scientific problems.  

Dr. Ezekiel J. Emanuel, the chairman of bioethics at the Clinical Center of the National Institutes of Health in Bethesda, Md., seems to support the outsourcing of clinical trials:  ”More places outside the United States are participating in research — is that a bad thing?” 

Dr. Emanuel cited a clinical trial of the Merck drug Gardasil, a vaccine against the human papilloma virus, that was conducted in Costa Rica, where there is a high incidence of the disease. “This is the kind of case where it is a good thing.”

Whatever the interpretations, the use of offshore clinical trials is growing. In the last 10 years, the proportion of United States-based researchers who direct clinical trials registered with the federal Food and Drug Administration has declined significantly, while the percentage of F.D.A.-registered researchers outside the United States has significantly increased, according to a report in January by the Tufts Center for the Study of Drug Development in Boston.

In 1997, about 86 percent of F.D.A.-registered principal investigators were based in the United States, the Tufts study said. By 2007, only about 54 percent of about 26,000 F.D.A.-regulated chief scientists who conducted clinical trials that year were based in the United States. 

In the end, Dr. Emanuel concludes, “It’s not a sufficiently nuanced concern to give it credibility.”

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