GLOBALIZED HEALTH RESEARCH AND REGULATION

Increasing globalization of biomedical research, especially drug development, testing, and regulation was also raised as an important issue among participants. Dr. Pazdur noted the international scope of oncology and the globalization of clinical trials, and stressed “our need to embrace it rather than flee from it.”

The vast majority of clinical trials accrue patients internationally, not only from Western Europe but from Eastern Europe and Asia. “Is this a good thing? Yes. It provides answers more quickly. It provides information on subpopulations in the United States, as we are a nation of immigrants with an ever-increasing presence of Hispanic and Asian populations. So to have representation of these people in clinical trials is extremely important,” Dr. Pazdur said. Dr. Lowy agreed with this statement, adding that the HPV vaccine he was involved with was tested internationally, which he thought was important given that the vaccine is destined to go to different populations, and “it is critical to be sure that your intervention is going to work across populations, and not just be useful for a particular population,” he said.

Dr. Pazdur added that “it doesn’t work in the economics sphere to be a protectionist, nor does it work in the scientific sphere.” He suggested that the Cooperative Groups, which are responsible for running many of the major clinical trials of oncology drugs in this country, coordinate their efforts with international studies. He noted that there have been international clinical trials in which Cooperative Group trials have participated, with pharmaceutical companies running the European components of the trials. Dr. Pazdur encouraged more of these collaborations, rather than viewing the Cooperative Group trials as being in competition with international clinical trials. He said the quality of data emanating from these international trials is generally good, and the trials represent the standard of care in the United Sates. “For us to try to cast doubt on these trials by implying that they are inferior really kind of smacks of a protectionism that probably doesn’t benefit anybody in the long run,” Dr. Pazdur said.

Dr. Rothenberg pointed out, however, that international trials can have their own set of complications. For example, in a crossover trial, patients whose disease progresses on an experimental therapy are allowed to cross over to another therapy. Yet the type of subsequent therapy given to patients may vary from country to country, so “how will the selection of regions in



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