Drugs are tested in clinical trials because not everything is yet known about them. So there may be drawbacks to treatment, which will not be uncovered until after treatment begins. Your physician will discuss these potential risks with you. You must carefully weigh them against the possible benefits, and ask as many questions as you need to. Keep the following in mind when evaluating risks.

• Sometimes the risks, or side effects, may be no worse than those of your current treatment options. Other times, the side effects may seem greater.
• You may react differently from another patient when given the same drug. Preclinical testing in the laboratory can often give scientists and physicians an idea of what patients may experience in the clinical setting. But every patient is different. Your physician will ask you a lot of questions ahead of time to learn as much as possible about your medical history in order to reduce the potential risks.
• In addition, the risks associated with clinical trials can vary depending upon the disease being treated. These risks are carefully weighed and balanced by your physician, the study physician, the Food and Drug Administration (FDA), and an Institutional Review Board (IRB). An IRB is a group of doctors, scientists, patient advocates, legal representatives and clergy which reviews a clinical study for safety issues.
• If something shows up that is a threat to patients in the clinical trial, the patients will be notified by the investigator and the trial may be stopped or placed on hold until more information is known.

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