Nurse Lugo: Clinical trials: hope or guinea pig?

You’ve seen the ads around Central Florida inviting you to participate in investigational studies. You may have had a local physician suggest that you participate in one of his or her studies. Most of these studies, called “clinical trials,” test new drugs to figure out the right doses and to assess if they are safe and effective before they are approved by the FDA for sale in the U.S.

A clinical trial for a drug has four phases, each with a different purpose.

Phase I determines the safe dose and the side effects.

Phase 2 tests the drug’s effectiveness and safety.

Phase 3 tests to see if the drug is better than what we currently use to treat the problem or compared to no treatment at all. Since it is a study, you may be randomly assigned to the group that gets the medication or to the group that gets the current standard treatment or no treatment. Usually, you don’t know which group you are in until the end of the study.

Phase 4 trials are the continued monitoring of a drug’s risks and benefits after it is on the market. Some rare side effects may not be known until the drug is used by thousands of people in the first few years the drug is sold.

Who are they for? Criteria for each trial are different. Many are for specific age ranges, and some are only for men or only women. Some studies recruit only healthy people, while others target people at specific stages of a disease or condition.

Should you do one? It depends. Everyone has to make his or her own informed decision. Consider the risks and benefits. As you can see, the risks and benefits are different for the different phases of the study.

The benefits could be better health. You could have access to promising treatments that are not yet available any other way. Or the benefits could be intangibles, like knowing you are helping find a cure for the problem you face.

You could also have side-effects and complications from the study, which may have been unknown when you start the study. After all, part of the study is to discover the side effects. Or you might have known side effects from a drug that the study later shows didn’t help your problem at all.

A committee, called the Institutional Review Board (IRB), must approve every clinical trial in the U.S. The IRB tries to be sure participants’ rights are protected and that the risks are as low as possible and worth the potential benefits. The IRB also ensures participants have key information, including the study’s purpose, what is involved, and the potential benefits and the risks. The IRB makes sure the information is on the consent form, and that the form also lets you know you can withdraw from the study at any time. Typically, the informed consent is a written document with extensive explanations that you sign if you decide to participate. Take your time to read it and ask questions. Find out about any possible costs involved. Many studies provide the study-related tests and treatments for free, but not all. Some pay participants. Ask who pays for medical care needed for any complications from the drug. Some insurance plans specifically exclude coverage for any experimental treatments, which includes clinical trials.

A clinical trial may be just right for you. Or maybe not. The more you know, the better your decisions will be for you. Find out more at clinicaltrials.gov

Maitland resident Nancy Rudner Lugo is a nurse practitioner and president of Health Action, offering workplace health consulting and nurse coaching. Visit www.healthaction.biz