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Clinical Trials: You Don't Have to Be Sick to Participate

Joan H. Allen | 10/27/2010, 9:05 p.m.

Heart disease and cancer are the first and second leading cause of death for African-Americans nationally. Cardiovascular diseases rank as the number one killer of African-Americans claiming the lives of over one-third of the more than 292,000 African-Americans who die each year.

The rate of high blood pressure in African-Americans is among the highest in the world at about 44 percent. African-Americans develop high blood pressure earlier in life and have much higher average blood pressures compared to whites, contributing to a higher rate of fatal stroke. Diabetes is the fifth leading cause of death among African-Americans.

African-American men are more likely to develop and die from some diet-related cancers, such as prostate and stomach cancer than white men. African-American women are more likely to die from some diet-related cancers, such as colon and rectum and stomach cancer than white women. African-Americans are also less likely to survive for 5 years after being diagnosed with cancer than whites.

This may be due in part to barriers to the receipt of timely or quality medical care, which results in diagnosis at a later stage when the disease has spread to other tissues.

Although these statistics are alarming, African-Americans now have a better chance than ever before to become more knowledgeable about, and take advantage of, the options for improved health care. When President Obama's administration announced, through the American Recovery and Reinvestment Act in partnership with the National Center on Minority Health and Health Disparities, a major "GO GRANT" with only three weeks to apply, Dr. Claudia R. Baquet, associate dean, Office of Policy and Planning and director of the National Bioethics Research Center at the University of Maryland, felt she had a good chance of obtaining it.

"These grants were awarded to those scientists that have an outstanding track record in the field and are ready to rapidly start the critical programs i.e. hit the ground running," said Dr. Baquet, a trailblazer in the field of bioethics, health disparities and clinical trials.

She was successful in her application to secure the funding to, in part, call attention to the heightened mortality rate among African-Americans and the need for early diagnostic testing. Also, many African-Americans do not take advantage of the free testing and screenings that are currently available to underserved and uninsured individuals.

What is also vitally important to stemming the crisis in health care, besides prevention and obtaining standard care is the clinical research obtained through clinical trials.

Dr. Harold P. Freeman, president and founder of the Ralph Lauren Center for Cancer Care and Prevention in New York and senior advisor to the director of the National Cancer Institute (NCI) in Bethesda, Md., has studied health disparities for over 40 years. He discussed the importance of the study of health disparities and the participation of African-Americans in clinical trials.

"I think the study of health disparities is so important because people have not benefited equally in the prevention of cancer and other diseases ... It's a matter in my mind of equity and justice, that's the fundamental issue that has to be addressed," Dr. Freeman said.

"I think that the most important reason for African-Americans to participate in clinical trials is because if you participate in clinical trials, you will get better treatment. You'll either get the treatment that is standard treatment or you'll get a treatment that is being tested against that treatment. Often that treatment is at a higher level," he said.

Fears from past abuses, including the government-sponsored Tuskegee syphilis atrocity, often give pause to those considering clinical trials. Dr. John M. Palmer, executive director, Harlem Hospital Center and the Renaissance Health Care Network said, "Historical events have given African-Americans reason to mistrust clinical trials. But clinical trials show us what works and what doesn't in medicine. It is as important as ever to ensure diversity among clinical trials participants, particularly as we gain evidence that certain drugs have different effects on African- Americans as they do on Caucasians."

One doesn't have to be sick or dying to participate in a clinical trial. Diseases can also be prevented through clinical trials. "There are several types of clinical trials," explained Dr. Baquet. "There are, one, treatment trials, two, prevention trials, three, early detection/screening and diagnostic trials, four, genetic trials - which are new; and five, quality of life and supportive care trials. What is important for the public to know is that you don't have to be dying to get the advantages of clinical trials.

You can have a stage of disease that is still curable where you can get a better treatment and higher survival."

There's currently a Screening for Gastric Cancer in High-Risk Population for first degree relatives of patients with gastric cancer. There are also prostate clinical trials for individuals who have high incidents in their family and every other disease. Currently there is a Low-Fat Fish Oil Diet for Prostate Cancer Prevention study that is looking for participants to study the benefits of Fish Oil and Vitamin E on prostate cancer prevention.

In addition to African-American avoidance of clinical trials, race discrimination in clinical trials has also been rampant. In 1993, the National Institutes of Health (NIH) Revitalization Act was amended to require the inclusion of women and minorities in clinical and government sponsored human subject research. A recent successful breast cancer treatment was found to have been developed with very little African-American participation.

There was such a protest from many of the African-American breast cancer support groups that the study was redone with African-American women.
"It is well known that African-Americans are under-represented in clinical trials yet they experience many health disparities. Lower participation of African-Americans and other underserved communities in clinical trials is a contributing factor in health disparities," says Dr. Baquet. "Plus, this impedes even more advances in public health and medicine. Clinical research is dependent on the participation of diverse patients."

Besides medical treatment, some individuals participate in clinical trials to obtain free services, as well as a monetary benefit. One individual said she routinely participates in clinical trials for skin care, perms and beauty products, which she is compensated for by the cosmetic company L'Oreal.
Regardless of reasons to participate, there are public policies established to protect the general public from abuses.

The Office of Human Research Protections (OHRP) and The Institutional Review Board (IRB) were also established to help guide medical professionals and participants in clinical trials with the basic guidelines of their rights and obligations in medical experimentation.

"The clinical trials that are allowed have to go through such a rigorous process," Dr. Freeman explains. "You can't just do a clinical trial. You've got to pass a robust series of requirements and get approved to do a clinical trial. A lot of analysis, and IRBs, really look at the safety of the new treatment that's being recommended. So when it gets to the level of clinical trials, the research has been thoroughly scrutinized."

People must also protect themselves, says Dr. Baquet. "Until you truly understand what's contained in the Consent Forms," don't sign anything, she advises. Ask them, '"Is the study IRB approved? If so, let me see the IRB number' because sometimes they're not legitimate. After consulting with your doctor, it's important to make sure that all of your questions are fully answered prior to deciding whether a clinical trial is right for you."

There are always risks. "No treatment - whether it be standard treatment or clinical trials - is without any risks," states Dr. Freeman. "No one can ever assure that there could be no complication. Any treatment, say for cancer, even if it's a standard treatment, carries certain risks.

But, I don't believe that being in clinical trials...in general does incur any higher risks than standard treatment. It is the responsibility of the doctor who provides the clinical trial treatment to carefully explain the risk involved to the individual patient. Informed Consent is important in standard treatment and in testing a new drug."

Dr. Freeman's biggest concern, however, is that only 3 percent of adult Americans that have cancer are being treated in clinical trials and that 97 percent are still not receiving timely quality standard care.

You can learn more about clinical trials and their availability for all chronic illnesses and diseases in your area by logging on to www.clinicaltrials.gov. Please be sure to consult with your doctor before deciding to participate.

Joan H. Allen is an editor for the Daily Challenge. "Clinical Trials: A Legacy of Shame and Fear Addressed in 2010" is an eight-part series resulting from a partnership between the University of Maryland Bioethics Research Center and the NNPA Foundation.