Trials Aren’t Tribulations

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Published on Monday, 12 November 2012 17:53

Written by Ohio State Wexner Medical Center

The Ohio State University Medical Center patients and cancer survivors Derrick Dozier and Dr. Kimberly Bates participated in clinical trials. And both, who are healthy and vibrant today, are grateful they did.

“We aren’t going to know the information we need about treating African-Americans unless we’re equally involved in these clinical trials,” Bates says. “It’s a good thing to do.”

Enormous advances in everything from cancer to AIDS have been made possible as a result of clinical trials. And people’s participation in them continues to yield groundbreaking research into new medicines and treatments.

“The only way we make progress in medical care here and worldwide is clinical trials,” stresses William Hicks, MD, professor of Clinical Internal Medicine.   

Myths and facts
Still, myths linger concerning clinical trials. The most persistent one is that people participating in them will be treated with placebos. That misconception has its roots in the infamous Tuskegee syphilis experiment that occurred over a 40-year period starting in 1932. Disadvantaged black men were recruited unknowingly for an investigation to study the progression of syphilis. They thought they were receiving free health care from the government. The men were not told they had the disease nor were they treated for it.

Medicine and research have come a long way since this dark chapter in American history. For example, several layers of controls are now in place to prevent experiments such as Tuskegee from taking place today. Institutional Review Boards, which are located at institutions studying the drugs, make sure the risks and benefits are appropriate to what is being studied. Ohio State has three IRBs, staffed by physicians, scientists, patient advocates, clergy, community members and other healthcare providers. There are other protections from entities such as Data and Safety Monitoring Boards, and agencies funding the trials, like the National Institutes of Health. The Food and Drug Administration is involved as well in any trials involving treatment.

Susan Koletar, MD, principal investigator of Ohio State’s HIV/AIDS Clinical Trials Unit, points out that the purpose of Tuskegee — to study the natural history of syphilis — would never fly today. ”If you want to test a new medicine for a disease, it’s tested against the current standard of care, against the best medication that is already out there,” she explains.

As an example, 25 years ago, the first HIV drugs were tested against placebos because there were no HIV treatments available. After researchers found drugs that worked, new drugs were tested against the standard-of-care medications or combinations of medications. That practice continues today.

Trial Benefits
There are many benefits to participating in clinical trials. One is having access to the latest treatment, free of charge. Participants are monitored more closely and see research physicians and nurses more often. They may adhere to medications better because of the attention they receive.

“Studies show that people who participate in clinical trials for their disease do better than those who don’t because of the relationship that builds and because of more monitoring,” says Michael McDonald, program manager and outreach coordinator for the HIV/AIDS Clinical Trials Unit.

There is also an altruistic reason to participate in a clinical trial: to help others.

“That’s something people don’t realize a lot of times,” McDonald says. “They are part of the solution. They really are the reason we have the medications we have now in all disease states. Many people volunteered their time and their energy to make those medications available to the market.”

Puncturing the myths

No, you will not be subject to unscrupulous treatments. Nor will your body be used for dubious scientific motives. Misconceptions abound concerning clinical trials. Here we debunk a few of them.

Myth: I’ll be treated like a guinea pig if I participate in a clinical trial.

Fact: Trials are subject to several layers of safety checks, including evaluation by Institutional Review Boards and data safety monitoring boards. Those participating in trials should not hesitate to ask questions.

Myth: All clinical trials focus on treatments.

Fact: While treatments are one aspect of the research, trials also deal with better ways to prevent the disease and better ways of diagnosing it. Clinical trials dealing with survivors are just as important.  

Myth: I may be forced to do something I don’t want to do in a clinical trial.

Fact: There is a rigorous informed consent process before anyone can participate in a trial.

Myth: I won’t receive the latest treatments.

Fact: Clinical drug trials test new medicines against the standard of care. This means that recipients will receive either the current drug or a new treatment.

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