Color-blind? The value of racial data in medical research

Subset analysis by ethnic group has become one of the standard ways to crunch the numbers that come out of clinical trials. Advocates say the process generates hypotheses worth pursuing. Critics charge that while such hypotheses may be colorfully attractive, they're often spurious.

By Victoria Stagg Elliott, AMNews staff. Jan. 5, 2004.

Late last year, VaxGen Inc. announced the much-anticipated results of its phase III AIDS vaccine trial. But the data released by the Brisbane, Calif., biopharmaceutical company ultimately caused more confusion than conclusions.

Though the vaccine showed no efficacy within the study population, a subset analysis seemed to suggest that African-Americans and Asian-Americans experienced some benefit.

So did the vaccine work or not?

At the time, the data seemed to indicate that it might for some people. Subsequent results from a trial in Thailand exclusively among Asians found no efficacy. And similar conclusions from a National Institutes of Health analysis are expected this year. A VaxGen spokeswoman said the company would like to do a trial focused on an African-American study population to settle the question, but does not have the funding.

Now, as the dust is settling, critics point to the episode as an example of what can happen when selected data are given too much weight too soon.

"It was a desperate act by a company that was trying to save a failed product," said Mark Feinberg, MD, PhD, a professor of medicine and HIV specialist at Emory University School of Medicine in Atlanta. "If they really cared about racial and ethnic differences, they would have structured a very different trial."

But there is also a scientific contingent that sees value in this kind of numbers crunching.

Thus, the VaxGen story is not only about a vaccine and a certain degree of puzzlement. It also highlights the debate about the role race and ethnicity play in clinical trials.