Clinical Trial Basics

Clinical trials are research studies that test new, potentially beneficial, medical Less May Be More in Comforting Cancer Survivorsinterventions on people. In most cases, the intervention is intended to prevent, diagnose or treat disease, manage symptoms associated with that illness or mitigate side effects from treatment.

Regardless of the intent, the trial seeks to answer two important questions: Is this intervention safe? Is it effective?

While trial designs vary widely, most ovarian cancer studies include comparisons between the new drug and the standard of care (the therapeutic plan proven to help many patients). These are the test and control groups. The test group receives the new drug, which is sometimes added to the standard of care. The control group receives the standard of care plus a placebo, an inert substance that looks like the drug being tested. By measuring the different responses in each group, researchers can determine if the drug is safe and effective.

The U.S. Food & Drug Administration requires rigorous trials before any new intervention can be approved. As a result, trials are a critical component in any efforts to improve patient care.

Keeping an Open Mind
Many people have the misconception that clinical trials only come into play for patients with no other choices. This is both incorrect and dangerous. It’s incorrect, because there are trials that can help patients regardless of their disease stage. It’s dangerous because patients can wait too long. By the time they seek out a trial, their disease may have progressed too far or their previous treatments could eliminate them from consideration. As a result, they cannot participate in a trial that might have helped them. See How Trials Work for more information.

Who Can Participate
Clinical trials have standards, also known as eligibility requirements, that determine who can or cannot participate based on specific characteristics, such as the stage of the cancer, treatment history, medical conditions and other factors.

To be included in a trial, a person must volunteer to participate, understand what is being tested, and acknowledge the potential risks and benefits associated with the study.