What are clinical trials?

Clinical trials are research studies done to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

Why are clinical trials done?

Clinical trials are done for several reasons:

• To determine whether a new drug or device is safe and effective for people to use.
• To study different ways to use current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
• To learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.

Who should consider clinical trials and why?

People have many reasons for participating in clinical trials. These reasons include the lack of effective treatment available, intolerable side effects of available treatments, and the desire to contribute to the advancement of medical knowledge.

Where are clinical trials conducted?

Clinical trials are sponsored by Federal agencies (such as the National Institute of Health), organizations (such as pharmaceutical companies), or individuals (such as healthcare providers). The sponsor determines the location(s) of the trials. They are usually conducted at universities, medical centers, clinics, hospitals, or other research sites.

Are clinical trials safe?

There are regulations and guidelines for clinical research designed to protect participants from unreasonable risks. Researchers are required to give prospective participants complete and accurate information about what will happen during the trial as well as the potential risks of participating in the trial.

What should I think about before joining a clinical trial?

It is important to learn as much as possible before joining a clinical trial. You should discuss your questions and concerns with your healthcare team and your family or friends. Be sure you understand what is expected of you during the trial, the type of health care you will receive, any related costs for the care you receive during the trial, and the benefits and risks associated with participating.

What are the potential benefits of participating in a clinical trial?

There are many potential benefits of participating in a clinical trial. These benefits may include:

• Access to new treatments often not available outside the clinical trial setting
• Treatment that may be more effective than the standard approach
• Close monitoring, advice, care, and support by a research team of doctors and other healthcare professionals who understand your disease or condition
• The opportunity to be the first to benefit from a new method under study
• The chance to play an active role in your own health care and gain a greater understanding of your disease or condition
• The chance to help society by contributing to medical research. Even if you don’t directly benefit from the results of the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.

If my doctor suggests a clinical trial, do I have to participate?

Participation in a clinical trial is never mandatory. Your doctor will always discuss all the treatment options with you. If you choose not to participate in a clinical trial that your doctor has suggested, your doctor will explore other treatment options with you.