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January 1, 2009 – Vol. 3 • No. 5
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The ins and outs of medical research

Ben Perkins, 43, is on a mission.

For years, he has worked as a community educator trying to raise awareness of the need for more African American involvement in HIV/AIDS research.

Perkins is also a bit of a maverick. He has participated in several clinical trials; as a gay black man, he says he believes that he owes it to the black and gay communities.

“It’s one thing to talk about it, but another thing to actually roll up your sleeves,” he said.

For Perkins, it’s personal. Many of his friends are HIV-infected. “HIV has had a profound impact on me,” said Perkins. “My childhood best friend died of AIDS.”

Taking part in a clinical trial is voluntary. But participation has been highly skewed to include mostly whites, men and those with higher levels of income. Minorities, the elderly, women and those from rural areas are largely excluded.

There are reasons for the gap — chief among them the higher degree of mistrust among African Americans. But other barriers exist.

Insurance may not pay for the study; the requirements can be time-consuming and demand time away from work; transportation may not be available; language differences present a problem; and the study may be too complicated to understand.

For many, it is merely lack of awareness — people may not know that participation in a clinical trial is possible.

Part of the problem lies with the medical profession itself. Primary care physicians and those not affiliated with research institutions may not be aware of patient eligibility for clinical trials. Some physicians simply do not make referrals. More significantly, minority investigators, who may be more successful in attracting minority volunteers, are under-represented in research.

Programs are in the works to increase participation by minorities and women. On a national level, the National Institutes of Health now requires researchers to design strategies to include under-represented groups. Medicare authorized payment of routine costs back in 2000 for Medicare recipients who participated in clinical trials.

On the local level, community-based partnerships, including the Program to Eliminate Health Disparities at Harvard School of Public Health, are developing initiatives to increase awareness and understanding of clinical trials among blacks to improve their participation.

For the record, anyone can participate in a clinical trial if he or she meets the specific inclusion criteria, such as age, gender, extent or type of disease, previous treatment and other medical conditions.

The potential benefits are enormous. A person can play a more active role in his or her health care, have access to new treatment before it is made available to the general public, and obtain closely monitored expert medical care. And they can make a major contribution to science and help others.

But there are risks as well. Unpleasant side effects — some potentially life-threatening — are always a possibility. Worse, the experimental treatment may not be effective.

“I understand people’s hesitation,” Perkins said. “It’s a big deal. You’re putting your body on the line.”

Clinical trials are conducted in four sequential phases. Phase I trials test the safety of a new treatment, while Phase II trials test the effectiveness of that treatment.

If the results of the first two phases look promising, Phase III trials then determine whether the experimental treatment is better than the current standard treatment. If successful, the research team can request approval by the Food and Drug Administration to make the treatment available to the public.

In some instances, a Phase IV is added to continue to monitor the long-term effect on people who use the experimental treatment even after federal approval.

Stringent guidelines for clinical trials are in place to protect the safety of volunteers. The Data Safety Monitoring Board oversees safety data and warns researchers and participants if they notice a trend towards excessive risk. The research plan — or protocol — is reviewed by the federally mandated Institutional Review Board (IRB), a group of health professionals, statisticians and laypersons.

The IRB monitors the progress of the trials, checks for side effects and can request periodic modifications. Most important, the board can terminate the trial if preliminary results are not satisfactory.

Such was the case with the latest protocol to which Perkins had consented.

Sponsored by the National Institute of Allergy and Infectious Disease and Merck & Co., Inc., the Step study was designed to evaluate the safety and effectiveness of an investigational vaccine for HIV. The Step study was a Phase 11b clinical trial that enrolled HIV-negative volunteers to receive either the study vaccine or a placebo, an inactive substance.

“It was important to me to find a cure or a vaccine,” Perkins said. “I wanted to make a difference and contribute to the body of knowledge to decrease the incidence of HIV.”

Perkins admits that he was a bit apprehensive about receiving injections of an unknown substance. But he is just as quick to point out that the potential benefits greatly outweighed any minor psychological anxiety.

Unfortunately, the study was terminated early. The results were not promising, the researchers determined, and their objectives were unlikely to be met.

Though the vaccine did not perform as intended, Perkins is still involved with the trial. Every six months, he receives examinations to determine the long-term effects of the experimental drug.

Perkins is a project director at the Fenway Institute, an interdisciplinary center for research, training, education and policy development. The institute is part of Fenway Community Health Center.

Perkins is a bit philosophical when it comes to clinical trials.

“I look at it,” he explains, “as an act of love — for oneself, the community and for those who come behind.”

Ben Perkins, a project director at The Fenway Institute, was a volunteer in a clinical trial to develop a vaccine for HIV.

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