When California-based VaxGen announced in February 2003 that its HIV vaccine selectively protects blacks from infection, experts questioned the statistical significance of the results. Out of the resulting controversy has emerged a real push to change the way minorities are recruited and retained in HIV vaccine trials.

“We have learned some important lessons from the AIDSVAX trial,” says Peggy Johnston, director of AIDS vaccine research at the US National Institute of Allergy and Infectious Diseases. “We have to ... apply it to the future so we don't end up in this situation again.”

In response to VaxGen's announcement, a US National Institutes of Health (NIH) working group reanalyzed the data and concluded that the protective effect observed in certain subgroups was a fluke. The group said the minority population in the trial was too small to detect any differences.

“The study population should mirror the people who are at the highest risk, and in the VaxGen trial, this simply was not the case,” says Mark Feinberg, a professor of medicine at the Emory University School of Medicine. What's more, Feinberg says, VaxGen's claims actually make recruiting minorities for clinical trials more difficult.

“People from diverse racial and ethnic backgrounds are already skeptical of scientific researchers,” he says. “The publicity generated by the AIDSVAX trial makes a complicated situation even worse.”

Although the NIH set guidelines on minority participation in clinical trials in 1994, the numbers of women and people of diverse ethnic backgrounds in trials remain low. “This means that broad and deep community support will be needed, rather than a narrow focus on recruitment for a particular trial,” says Steve Wakefield of the HIV Vaccine Trials Network (HVTN).

At a conference in September 2003, researchers renewed their commitment to making trials more representative of populations at risk. In October, the US sponsored a symposium on recruiting and retaining racial and ethnic minority participants in clinical trials.

As a result, the HVTN and the NIH are working closely with community leaders to engage local organizations, develop community education plans and build trust among minority populations.

“The challenge,” says Wakefield, “is to turn all of this into realistic activity which addresses the legacies of mistrust in communities of color.”

This material is part of Nature Medicine's 10 year anniversary series. For more content related to these special focus issues, please see http://www.nature.com/nm/special_focus/anniversary/index.html