WASHINGTON — A new initiative was launched on Wednesday to boost the participation of minorities in clinical trials and correct a long-standing imbalance that experts say has hurt medical treatment for some underrepresented groups.
The national campaign, created by the Pharmaceutical Research and Manufacturers of America (PhRMA) partnering with the health care group the National Minority Quality Forum, is called "I'm in" and was presented at a press conference.
“What we’re talking about now is medicines for a bio-diverse America,” said Gary Puckrein, the president of the National Minority Quality Forum, a nonprofit that focuses on improving health care for minority populations. “How do we get the appropriate representation of patients into trials? How do we do it efficiently and quickly and really break open the 21st century?”
Developing new medicines relies on the participation of volunteers in clinical trials, in which researchers evaluate new treatments to ensure they are safe and effective. But Hispanics, black Americans and Asian-Americans, among others, are conspicuously absent from many of these trials.
For instance, although African-American men are twice as likely as white men to suffer from fatal cases of prostate cancer, they represent only 4 percent of participants in prostate cancer trials. Similarly, although the Hispanic community is significantly more likely to be affected by diabetes, Hispanics were only 4 percent of diabetes clinical trial participants from 1998 to 2001 and make up an even more dismal 1 percent of clinical trial participants overall.
That has led to holes in data about how different groups will react to various treatments, as well as the neglect of research on certain ailments relative to others.
The new campaign seeks to boost the number of minorities who take part in clinical trials by raising awareness of the issue, partnering with hospitals and physicians that serve those communities and launching a new website to encourage participation by interested individuals. Another website will serve as a resource for authorized researchers seeking participants, providing an array of tools to aid in recruitment of diverse participants.
A dollar figure on how much was spent on launching the campaign was not immediately available.
There is an urgent need to address the problem as the demographic composition of the American population continues to shift and breakthroughs in science allow medicines to be increasingly microtargeted toward specific genetic pools, leaders of the initiative said.
Asked why such an effort had not been attempted in the past, John Castelleni, president and CEO of PhRMA, attributed it partially to “institutional inertia.”
“We’re very good, like every other sector in the world, [at] doing what we’ve always done the way we’ve always done it,” he said. “But the imperative is that the science has changed, and so as the science has evolved, as we have taken advantage of decoding the human genome, we’ve recognized that the future of medicine is in medicines that are going to be aimed more and more at genetically homogenous populations.
“If those populations are not participating in clinical trials, we’re not going to be able to deliver on that promise to patients,” he said.
Puckrein added that companies had tried to tackle the challenge individually, but he hoped an industry-wide effort would prove more effective.
In the early 1990s, the lack of women and minorities participating in trials conducted by the National Institutes of Health came to light, culminating in Congress mandating in 1993 that at least NIH-funded studies be more inclusive. But the law did not affect trials sponsored by private researchers and industry.
For Averl Anderson, the issue is personal. In 2009, Anderson, now 60, was diagnosed with an aggressive form of stage 3 breast cancer prevalent among African-American women. She credits treatments tested on other black women through clinical trials for saving her life.
“I feel if it were not for other 55-year-old African-American women who participated in a clinical research trial, I might not be standing here talking to you today,” she said. “I thank God that today’s cures were yesterday’s clinical trial, and today’s clinical studies are tomorrow’s cures.”
Initiative organizers noted that there were stigmas to overcome, particularly in minority communities. Among African-Americans, the legacy of the infamous Tuskegee experiments, in which black men were used as subjects in a syphilis research study without their consent, lingers.
“Certainly in the African-American community, there’s a record there that lays the foundation of that distrust,” Puckrein said. “There are genuine reasons people have concerns, but this is about saving your life and how and why you should participate to help us accomplish that.”