Clinical Trials: Treating Tomorrow Today

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George Watters found out he suffered from an aggressive form of liver cancer when his doctors opened him up to perform a biopsy. Because his disease was so advanced, the 60–year–old San Francisco man opted to participate in a new drug trial, taking a treatment step many African–Americans skip.

By doing so, they are missing out on a very important health care opportunity: the clinical trial.

Most clinical trial volunteers are white. Fear keeps many Black Americans away from clinical trials because they know about Tuskegee Institute studies from the 1930s, when a group of Black men with syphilis were followed for four decades without treatment.

Some good, however, came from the Tuskegee fiasco, says Otis Brawley, MD, associate director for cancer control and chief of the solid tumor service at the Winship Cancer Institute at Emory University. Trials sponsored by government agencies like the National Cancer Institute and the Department of Defense are strictly regulated and must pass an institutional review board not connected with the research. Board members, usually from the community, scrutinize study protocols and evaluate appropriateness. These protocols were instituted to keep disasters like Tuskegee from happening again. So participants in today’s clinical trials have access to medicines that will become the treatment gold standard.

Many African–Americans feel more comfortable participating in trials conducted by Black physicians. Until recently, white doctors have done the lion’s share of studies, because pharmaceutical companies testing new medications targeted them most frequently. Thanks to the National Medical Association’s (a professional organization for primarily Black doctors) promotional efforts, more African–American physicians are conducting trials. But statistics show race is not a factor in determining outcome, particularly for cancers of the breast, colon, lung and prostate. Equal treatment produces equal outcomes, regardless of ethnic background, so Dr. Brawley opposes segregated studies.

If you want to be in a clinical trial, ask your doctor, who is often the best, most knowledgeable resource. Then participate in the informed consent process and meet with the doctors and nurses conducting the study. Review and sign the patient consent form, which outlines:

  • what the study is
  • why it’s being done
  • who is eligible
  • expected results
  • known risks and side effects of drugs used
  • how patients can withdraw

Before participating in a clinical trial, ask these questions:

  1. Who is sponsoring the research–a pharmaceutical company, a government agency like the NIH, or someone else?
  2. Who do I know in the medical community who can advise me about participating?
  3. Why am I taking this medicine and how will I benefit from it?
  4. What are the risks involved?
  5. Do the benefits outweigh the risks?

There are three types of clinical trials:

  1. Randomized–testing two commonly accepted therapies and comparing them. Patients are randomly selected by computer to determine which treatment they receive.
  2. Blinded–patients are not told which drug they will receive; sometimes doctors do not know either–these are double–blind trials.
  3. Placebo–patients in these trials may receive either a medication or a sugar pill that will not have any effect. Placebo trials are used to treat less serious conditions.

Investigate clinical trial opportunities near you. Here’s how:

  • ask your doctor for referrals
  • contact your nearest research university for a list of current studies
  • volunteer if you do not have a disease; healthy volunteers are part of a control group.

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