BACKGROUND: More than 40,000 clinical trials are currently underway in the United States.

The benefits of clinical trials are two-fold. They can sometimes help patients by providing them with access to groundbreaking treatments and they can help advance medicine; but there is a dark side of the trial process.

There are serious risks to volunteers who enter clinical trials, ranging from negative side effects to death.

According to Michael Grodin, M.D., a professor and director of the law, medicine, ethics and human rights program at Boston University's school of public health, the general public's mentality toward clinical trials has shifted over the last five to ten years.

"There was a time when research was seen as bad and only poor people and people in prisons were researched on," Dr. Grodin explained. "There is a bad, horrible history of using people as research subjects. Then all of a sudden, I think partially because of the AIDS epidemic, people started thinking research is really good and you want to be in a research trial, so people demanded access to research trials."

DIFFERENT PHASES: Clinical trials are typically broken down in pre-phases, three main phases, and sometimes a fourth post-phase.

The FDA will usually approve a drug or treatment that passes the three main phases of testing.

Preclinical studies involve in vitro studies done in a test tube or laboratory, and animal research.

Phase I trials are the first stage of human testing and are normally performed on a small group of human volunteers. Usually phase I volunteers have tried many other treatments and have limited options left.

Phase II trials are started after the initial safety of a drug or treatment is approved using the outcomes of the Phase I trial. Phase II trials are performed on a larger group of volunteers and are designed to measure the clinical efficacy of a drug or treatment.

Phase III trials are usually randomized controlled trials performed on an even larger group of patient volunteers, and are a definitive assessment of the drug or therapy.

If a drug or treatment is approved after passing a phase III trial, a phase IV is sometimes conducted to test its ongoing effects.

Before entering any phase of a clinical trial, Dr. Grodin warns patients to ask questions about what the goals and risks are to joining the study. He also cautions that very few early phase clinical trials are aimed at providing benefits to the patients enrolled.

Later phases, particularly phase III trials, are more likely to benefit the patients who receive the drug or therapy because it has already passed preliminary trials; however, even in the later stages there is no guarantee the drug or treatment is effective.

QUESTIONS TO ASK: It's important to know exactly what you're getting yourself into before entering any phase of a clinical trial. The following are some important questions experts recommend a person asks:

What is the purpose of this study?

Who is going to be in the study?

Why do researchers believe the treatment being tested may be effective?

What kinds of test and experimental treatments are involved?

How do the possible risks and benefits compare with my current treatment?

How might this trial affect my daily life?

How could I potentially be harmed as a result of this treatment?

How long will the trial last?

Will hospitalization be required?

Who will pay for the experimental treatment?

Will I be reimbursed for other expenses necessary as a result of the trial?

What type of long-term follow up care is part of this study?

Who will be in charge of my care?

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