Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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United Press International - October 18, 2006
Gender balance in clinical trials is critical due to the proven differences in the effectiveness of various medical treatments, said public health researchers in the Journal of Epidemiology and Community Health.
For example, not enough women have been included in trials of new HIV treatments, they argued, and just one of the 117 European trials done between 1990 and 2002 "included any gender analysis."
The authors also criticized the European Medicines Agency (EMEA) -- Europe's equivalent of the U.S. Food and Drug Administration -- for failing to develop gender-specific guidelines or strategies for clinical trials without giving any justification.
The EMEA has acknowledges that female enrollment in the early stages of clinical trials -- when drug safety, dosing and side effects are assessed -- is lower than it should be, but "the agency does not consider this inadequate representation to be relevant," the study authors said. "When women are excluded, any specific dosing requirements for them will remain undiscovered until much later in the drug development process, if ever," they concluded.
The authors also argued that Europe should adopt the U.S. system, where female inclusion in clinical trials and analysis of gender-based differences in drug reactions and effectiveness are required.
However, they also acknowledged that upping enrollment of women patients in drug studies will be a challenge, due to the increasing cost of doing large-scale trials. Nonetheless, they said, "EMEA should use its muscle to ensure that sufficient work is done to protect the women who will eventually be using those drugs."
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