Doctors and nurses are encouraged to print and share this guide with their patients. The guide is available in an easy to print PDF format, and can be personalized with the treating physician’s contact information by clicking on the gray box on the second page.

What is a clinical trial?
A clinical trial is a research study involving human volunteers to evaluate new ways to prevent, diagnose, or treat diseases. Clinical trials help determine if experimental treatments are safe, effective, or better in some way than standard treatments.

What are the benefits of participating in a clinical trial?
Clinical trials are essential to the advancement of medicine. By participating in a trial, a patient may have access to a treatment that is new or better than standard treatment. By participating in a trial you are also helping others who may benefit from the findings in the future. Some patients also receive free medical care or are paid for their participation.

Why is it especially important for female and minority patients to participate?
Diseases affect everyone, but not in the same way. Therefore, it’s important to have people of all races, ages, backgrounds, and genders, so that the best way of preventing, diagnosing, or treating every kind of disease for every kind of person can be discovered.

Are clinical trials safe?
Before an experimental treatment can be applied to people, it is carefully studied in the laboratory to determine its effectiveness and safety. Clinical trials are reviewed at both the national level by the Food and Drug Administration (FDA) and at the local level by an Institutional Review Board (IRB). Each hospital or clinic where a clinical trial is to take place has an IRB made up of health-care professionals, patient advocates, and community leaders who review the trial for safety and fairness.

In addition, possible participants are also carefully screened – by thorough analysis of a patient’s medical history, physical examinations, or blood tests – to ensure that they are the best possible candidates for the experimental treatment. During the trial, patients are carefully monitored to track how the treatment is affecting their condition. Since participation in a clinical trial is voluntary, a patient can stop at any time for any reason.

What should you consider before participating in a clinical trial?
Before participating, you should be provided with an “informed consent” document explaining the risks and potential benefits of the trial. Be sure to read over this information carefully. It is important to fully understand the purpose of the trial that you are considering and what to expect.

You will want to find out if the treatment will affect any of your current medications or worsen any other medical conditions you may have. You should be informed about what tests or procedures, such as biopsies or blood draws, will be performed, and you should consider your comfort level with what will be done. Also, you should think about whether you are prepared for any anticipated side effects, pain, or discomfort that may be involved.

Another consideration is how the trial will affect your daily life. You should think about how long the study lasts, if it will fit in your work schedule and personal life, and if you can commit to it. Will the hours at the clinic require you having to take time off work? How many visits will be involved?

If you do decide to participate, be sure to request the contact information for someone you can call should any questions or concerns arise during the trial.

Are there any costs associated with participation in a clinical trial?
This is an important question you should discuss with your doctor. There may be extra costs for participating in a study that may or may not be covered by your insurance carrier. Some examples of extra costs include additional doctor visits, special blood draws, or the cost of administering experimental treatments.

Are there different types of clinical trials?
Yes, clinical trials are sorted into phases as described below:

Phase 1: These trials constitute the initial testing in humans and usually involve a small number of volunteers, typically less than 100. Generally, the primary goal of these types of trials is identifying the most appropriate and safe dose of a new medication for further study.

Phase 2: Once a drug is shown to be safe in people, it has to be shown to be effective – the primary goal of Phase 2 trials. These trials are generally longer, typically lasting several months to years, and involve more people, up to several hundred.

Phase 3: This type of trial involves large-scale testing in several hundred to several thousand people for a thorough understanding of a treatment’s benefits and side effects in a wide range of patients. Often, a new treatment in this phase will be compared to the standard treatment or to a placebo (an inactive substance that has no medical value). Phase 3 studies are usually “randomized” studies in which a patient is assigned to either the standard arm or to the experimental arm by a computer or other coinflip mechanism. The FDA usually requires a successful Phase 3 study showing that a new treatment is better than the standard of care before they will consider the treatment for FDA approval.

Phase 4: Further analysis of a treatment is considered in these types of trials, exploring such issues as cost-effectiveness, long-term effectiveness, or how a drug impacts a patient’s quality of life.

These four phases describe treatment trials. There are many other types of trials patients may be asked to participate in, such as prevention, diagnostic, screening, and quality-of-life trials.

How do you find a clinical trial?
There are many Web sites which list current clinical trials for a variety of diseases and conditions. ASH recommends the following: www.clinicaltrials.gov, www.cancer.gov/clinicaltrials, and www.centerwatch.com.

Talk with your doctor to find out if joining a clinical trial is right for you.

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