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VOL. 123 | NO. 55 | Wednesday, March 19, 2008

Research Model Seeks to Include More Minority Participants

By Rosalind Guy

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A local research network has developed a research model designed to bridge the gap in health care to underserved communities, especially the black community.

Using the method, the 31 ACORN network clinics have more than doubled minority participation in clinical trials.

The model is based on a simple concept that calls for enrolling more minority people in what's called "best-in-class" trials, said Dr. Steve Coplon, CEO of Accelerated Community Oncology Research Network (ACORN) and CEO of The West Clinic.

ACORN is a community of oncology clinics begun in 2002 by physicians at The West Clinic.

"We have a portfolio of about 100 clinical trials, what we call 'best-in-class' trials by disease type, and those trials are opened and initiated in various clinic sites around the country," Coplon said. "And as people are undergoing their cancer therapy, they have the opportunity, by their own choice, to participate in a clinical trial."

The availability of clinical trials to all populations provides a treatment that is the standard of care of today, plus an additional treatment that may even prove to be superior, Coplon said.

"So anyone participating is going to get at least the best care of today, plus they may be getting the best care of tomorrow," he added.

'Everybody wins'

In the past, there was a disparity in cancer treatment that left blacks without some of the treatment options that other ethnic groups may have been receiving, he said.

While blacks make up about 12.9 percent of the U.S. population, they accounted for only 7.5 percent of all clinical trial participants in 2007, according to the National Cancer Institute. That number is down from 7.9 percent the year before.

NCI officials have attributed the low numbers to a variety of reasons. Those reasons can include physicians not bringing up the availability of trials with minority patients as well as a lack of information about the potential benefits of participating in clinical trials.

Using the ACORN research model, participating clinics were able to more than double the national average for minority participation in clinical trials.

In 2007, about 20 percent of ACORN's patients were black.

Coplon said the benefits of having a diverse group of participants in clinical trials is two-fold: the additional benefits the patients may receive by participating in the clinical trials and the data that will be provided to physicians about how different populations react to certain medications.

"First of all, it does help bridge the health disparity gap where, traditionally, black people weren't getting access to these best-in-class clinical trials; so that's the first, most important thing that it helps those patients," Coplon said. "The second thing is that we get data that helps in the broader context, whether it's African-Americans or Asians or Caucasians. ... The genetic profile of those patients results in different effects, different toxicities, different response rates, and those all help us improve the clinical decision-making as it affects the individual population. So everybody wins in the long run."

Once bitten ...

ACORN is comprised of oncology clinics throughout the United States. Physicians in the ACORN network all support its goal of opening the clinical trials to a broader population. And patients are thoroughly informed about research possibilities and learn that being a part of a study means they are closely monitored.

Historically, blacks have been hesitant to visit doctors or hospitals and few participate in studies that may seem experimental in nature, according to a recent study by researchers at Johns Hopkins University in Baltimore.

Part of the reason stems from a government-sponsored project involving nearly 400 black men who had late-stage syphilis. The 40-year project, titled the Tuskegee Syphilis Experiment, stretched from 1932 to 1972 and was conducted in Tuskegee, Ala. The men were told they were being treated for "bad blood," but reports have shown the physicians had no intention of treating the men for the disease. Instead, many of the study subjects were left to die so their corpses could be used to collect data.

Solemn promise

Still, the hesitancy of blacks to trust physicians has led, in part, to the disparity in health care in the community, Coplon said.

But the ACORN method takes that history into account and calls for doing everything possible to alleviate people's fears that they may be participating in something that is solely experimental.

"One of the most important things about this is that the clinical trials that are offered to patients, whether they be African-American or Asian or anyone else, are not truly experimental in the sense that with all of them you get today's standard of care and you may be getting today's standard of care plus an additional targeted therapy, which will become the standard of care tomorrow," Coplon said.

"So, everybody's getting at minimum the best treatment of today and I think, as we've learned how to educate patients and explain it to them and certainly as we've had physician champions, some of whom are African-American themselves, they're able to articulate that and educate the patients so they're not experiencing or feeling like there is some of the unfortunate history that's happened in health care. None of that is occurring."

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