What’s Behind Those Medical Breakthroughs You Read About? Clinical Trials

Highlights Thousands of people benefit each year from participating in clinical trials. What to Consider Prior to Participating in a Clinical Trial Click here. Want to know what it’s like to participate in a clinical trial? Click here.

You frequently read and hear about medical breakthroughs in the news. What you usually don't hear about are the thousands of thorough, time-consuming tests that are the precursors to medical breakthroughs. These unheralded studies are called clinical trials, and millions of people benefit from the results of these trials. What’s more, each year the trials help the thousands of people who actually participate in the trials.

What Is a Clinical Trial?

In order for a new drug or medical procedure to be approved by the Food and Drug Administration (FDA), it has to go through many steps. First, a new drug or procedure must undergo laboratory or animal studies. Then, the next step is to test it in people-based studies. These studies of humans are called clinical trials, and they are used to learn whether a new treatment is both safe and effective in patients.

Determining the safety and efficacy of a new drug or treatment usually requires 3 separate phases. Each phase is designed to answer certain questions. Knowing the phase of the clinical trial one is considering is important because it may give some idea about how much is already known about the drug or treatment being studied. (See the example of phase 1 trial at the bottom of this page.)

Clinical Trials Are Completely Voluntary

The ultimate purpose of a clinical trial is to answer a medical question, but this does not mean that the volunteers in the trial will not receive excellent, compassionate care. In fact, in a survey of more than 1,000 study participants, people were asked if they would enter a clinical trial again. Overall, 77% responded “definitely,” 20% answered “maybe,” and only 3% said “no.”

The decision to participate in a clinical trial, however, is a very personal one. While the benefits can be considerable, there are some risks as well. And both must be considered. Each person's situation is unique, so each will have different reasons for wanting or not wanting to volunteer for a trial. There is no right or wrong choice.

Weigh Benefits Versus Risks.

Each clinical trial offers its own opportunities and risks. But generally, clinical trials share some of the same potential benefits and risks:

Possible benefits:

• Access to treatment that is not otherwise available – treatment that may be safer or more effective than existing treatment options.
• Access to a greater total number of treatment options even if standard treatments have not yet been exhausted.
• Increased attention from one’s health care team and more careful monitoring of one’s condition and possible side effects from the experimental treatment.
• The possibility of payment by some study sponsors for part or all of one’s medical care during the study.
• A feeling of having more control over one’s situation.
• The possibility of helping others who have the same condition.

Possible risks:

• The new treatment may have unknown side effects or other risks, which may or may not be more severe than those from existing treatments. This is especially true of early phase trials.
• As with other forms of therapy, the new treatment may not work for everyone, even if it helps some.
• Some studies are randomized, so participants may not have a choice about which treatment they receive. Other studies are blinded, so participants and possibly their doctors will not know which treatment they are getting.
• Insurers do not always cover all of the costs associated with taking part in a clinical trial.
• There may be inconveniences such as more frequent testing, as well as time and travel commitments.

How to Find a Match to a Trial

The American Cancer Society helps patients find high-quality care in clinical trials that best match their medical needs and personal preferences, while helping researchers study more effective treatments for future patients.

Of the various clinical trial matching services available, the American Cancer Society chose to work with the Coalition of Cancer Cooperative Groups to provide a free, confidential, and reliable matching and referral service for patients looking for clinical trials. TrialCheck, a comprehensive database, is the result of their collaboration. The American Cancer Society believes TrialCheck is the most complete matching database of cancer clinical trials available.

The clinical trials information provided by TrialCheck is completely unbiased. It is updated every day, as is the contact information that allows patients to reach the doctors and nurses at cancer centers running each of the studies.

You can access the TrialCheck system through a toll-free number, 1-800-303-5691, or by clicking here.

Learn as Much as Possible

If you or someone you know is interested in a clinical trial, it’s important to know all you can about clinical trials. Knowing what to look for and what to expect ahead of time can be helpful. For a more complete discussion of clinical trials, click here.