All groups should reap the benefits
Karen Miller | 5/21/2015, 10:34 a.m.
Taking part in a clinical trial is voluntary. But participation has historically been highly skewed to include mostly whites, men and those of higher income. Minorities, the elderly, women and those from rural areas are largely absent from these trials.
Will it work for you?
Make sure you understand and are comfortable with a clinical trial if offered to you. A research team will oversee the study. Ask a few questions …
- What is the purpose of the study?
- Has it been tested before? If so, what were the results?
- Who is sponsoring the study?
- What tests and procedures are involved?
- What are the possible risks, side effects and benefits?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- How often will I have to visit the hospital or clinic?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this study?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
- If someone else in the study has an unexpected side effect, will you tell me?
- Can I withdraw from the study?
- Is it possible that I will be given a placebo instead of the drug under study?
Source: National Institutes of Health
There are reasons for the gap, chief among them the higher degree of mistrust among African Americans. It wasn’t that long ago in 1997 when President Bill Clinton apologized for the federal government’s role in the Tuskegee Experiment. Started in 1932, the 40-year experiment enlisted mostly illiterate sharecroppers in Alabama to participate in what they were told was a study on “bad blood.”
In reality, the study was on the ravages of syphilis, and the men were left to suffer its consequences even when a suitable treatment became available. Unfortunately, the lingering mistrust still looms large.
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; and language differences present a problem.
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 underrepresented 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 underrepresented groups. Medicare authorized payment of routine costs back in 2000 for Medicare recipients who participate in clinical trials.
Yet, even years after the implementation of these efforts, a report by researchers at University of California, Davis found that fewer than 5 percent of trials participants are non-white. The percentage is even lower for cancer research. While the incidence of cancer is highest among minorities, their participation in trials for cancer is only 1.3 percent.