Are Phase 1 Volunteers Vulnerable?

In the January 2008 issue of Archives of Internal Medicine, an NIH team led by Christine Grady reports the results of a study (Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?) surveying the demographics of patients who participate in phase 1 cancer studies. They report that these volunteers are overwhelmingly white, have pretty good physical functioning, earn above average incomes, have above average educational attainment, and do not lack for health insurance coverage. The authors then suggest that phase 1 volunteers "do not fit into any of the categories of vulnerable populations addressed by specific regulations."

This is an informative paper, though the results should not surprise anyone who has followed the field of phase 1 cancer research. Their use of National Cancer Institute (NCI) data is clever and comprehensive (though their anemic sample of 11 non-NCI studies is puzzling). And I agree with the tacit message: that regulators and ethicists should avoid infantalizing persons with terminal illness.

On the other hand, the article contains some misleading or debatable statements. The suggestion that phase 1 cancer volunteers "do not fit into any categories of vulnerable populations" is not exactly true: the Belmont Report implicitly categorizes the "very sick" as vulnerable. The World Health Organizations CIOMS policy states quite clearly: "Persons who have serious, potentially disabling or life-threatening diseases are highly vulnerable."

The view of vulnerability and autonomy espoused in this paper will strike many readers as thin and reductionistic– as if it were a box on a census form rather than an experience. So too is the suggestion that phase 1 study participants are not "in need of special protection." Nevertheless, this paper does help direct our concerns away from income and demography towardvariables that might really matter, like dependence, fear, and flux. (photo credit: Lutz-R.Frank 2007).