Why Clinical Trials Are Important

Clinical trials are conducted not only to determine the safety and effectiveness of new drugs, but also to test existing, approved drugs for use in treating a different medical condition.

Reasons to Participate in a Clinical Trial

These are just some of the reasons people choose to participate in clinical trials:

• Have an illness for which there is no current treatment
• Are unhappy with lack of effectiveness or side effects of current treatment
• Learn more about their condition
• Help others by contributing to medical research

Any Risks Involved Are Discussed in Advance

The clinical trial doctor carefully explains any known or potential risks associated with the investigational treatment so that a patient can make an informed decision about whether to participate or not. Prior to enrolling in the study, the clinical trial team will review the patient's medical history and perform any necessary lab tests to determine eligibility.

Overall risks are carefully weighed by scientists at the Food and Drug Administration (FDA) and an Institutional Review Board (IRB). An IRB is composed of doctors, scientists, community and patient advocates, as well as lawyers and clergy. Their role is to make sure that the safety and well-being of study participants are prioritized and protected.

Clinical Research Trials Are Divided Into Phases

It takes about 10 years to test a new investigational drug in clinical trials. In the first phase of research, the investigational drug is most often given to healthy people. Then it is given to a larger number of people who have the disease or condition being studied. Next, it is given to several hundreds or several thousands of people with the disease or condition to study its safety and effectiveness. Even after the drug is approved by the FDA, more trials may be done.

Some Clinical Trials Use a Placebo Along With the Drug Being Tested

A placebo is a pill that has no active ingredient but provides comparative value in medical research. Usually, neither the trial participant nor the medical team knows who is receiving the investigational drug and who is receiving the placebo.

If a condition requires treatment, such as anticoagulation therapy, a placebo would not be used and participants would receive either a standard drug (FDA approved and currently in use) or the investigational drug.

Participants Are Closely Monitored During a Clinical Trial

Participants typically receive more tests and evaluations during a clinical trial than they might during routine medical care. Physical exams, lab tests, and other evaluations are used to monitor the effects of the study medication throughout the trial.

Signing an Informed Consent Is Necessary for Participation

The informed consent document clearly describes: the trial, the length of the trial, the number of clinic visits, what tests are performed, any known and potential risks and the ability to withdraw from the trial.

The clinical trial doctor or nurse walks potential participants through this detailed document and it can be taken home to share with family or personal physicians. Only when the informed consent document is clearly understood, all questions answered, and signed can a person be enrolled in a clinical trial.

For more information, visit www.clinicaltrials.gov.