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Duke, NEJM Study Renews Debate on Global Outsourcing

Thursday, February 19, 2009

The ethics and safety behind the global outsourcing of clinical trials is once again being debated, with the release of a new study reporting that U.S. drug developers conduct most of their late-stage drug trials outside of the United States.

The study, published in Wednesday’s New England Journal of Medicine (NEJM), reports that the number of countries conducting drug testing has doubled in the past 10 years, and, in November 2007, a total of 13,521 of 24,206 investigative sites being used for studies sponsored by U.S. big pharma were international.

The globalization of clinical trials is not a new phenomenon nor is it necessarily undesirable. CenterWatch has reported about the increasing amount of clinical research being conducted in both emerging and western markets outside the U.S. for the past decade. Most clinical research conducted outside of the U.S. is done in Canada and Western Europe, areas of the globe with similar ethics and safety regulations. Many of these global trials are necessary for drug companies to register drugs in countries such as Canada, France and Germany as well as in large and growing pharmaceutical markets in China, India, Russia and Brazil.

The NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems. Emerging regions such as Asia-Pacific and Central and Eastern Europe look to both the FDA and the European Medicines Agency (EMEA) as models for their regulations governing clinical research.

But this latest study, authored by Duke University researchers, spurred articles in today’s Wall Street Journal and The New York Times that will only add fuel to the ongoing public debate of the benefits and risks of global outsourcing. The New York Times reports, for example, that some experts in the field say the NEJM study over-simplifies the data to elicit public alarm without providing any real evidence of wrong-doing or problems.

CenterWatch’s own research points to several problems with the study as reported by the Wall Street Journal:

  • The sample size is almost half of the trials listed at the time, compared to a more comprehensive analysis of clinical trials listed in August of 2007 done by Goldman Sachs.
  • The study’s analysis of the 20 largest drugmakers in the U.S. excludes more than 1,900 other companies developing drugs around the world.
  • Of the 20 countries outside the U.S. doing the most trials in August of 2007 (from the Goldman study), only four—Poland (13th), Russia (17th), Brazil (19th), and the Czech Republic (20th) could be considered emerging markets.
  • The percentage of clinical trials initiated overseas increased from about 13% in 1997 to about 30% in 2005. At the end of 2007, the number was just under 34%. The number of trials being conducted worldwide has gone from around 22,000 in 1997 to about 37,000 in 2007.
  • While the number of clinical trials initiated overseas has increased dramatically, the study overstates the share of trials overseas by more than 20 percentage points.

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