Clinical Trials

What Are Clinical Trials?

A clinical trial is a treatment option that compares a new treatment with a standard treatment. Clinical trials come in many forms of treatment, new drugs and therapies, surgeries and procedures and medical devices to name a few. Before a new drug or therapy makes it to a clinical trial, it has been tested rigorously in a laboratory.

Why Are Clinical Trials Important?

Clinical trials are important because the study treatment could become the new standard treatment. When a study treatment proves the goals it sets out to prove, a new standard treatment could result.

Clinical trials can benefit other people with your condition. Additionally, you have an opportunity to benefit by receiving a more effective treatment. This holds true for both the new study treatment and the standard study treatment.

What Are Some Advantages of Participating in a Clinical Trial?

Clinical trials provide high quality care. You are followed very closely when you participate in a clinical trial.

You have a chance of receiving a better therapy that you would not have had an opportunity to receive without participating in a clinical trial.

You could be helping other people with your condition.

What Are Some of the Disadvantages of Participating in a Clinical Trial?

You are followed very closely on a clinical trial. Although clinical trials provide an opportunity for high quality care, this sometimes involves extra clinic visits and procedures that may not be required otherwise. For some, this may actually be a disadvantage, especially if travel is involved.

You may or may not personally benefit from your therapy on the clinical trial. There is no guarantee the study treatment you receive is more effective.

Some study treatments or procedures may not covered by health insurance.

How Are My Rights Protected if I Participate in a Clinical Trial?

Your participation in a clinical trial is voluntary. Should you decide not to participate in a clinical trial, your decision will not affect your care in any way.

There is an informed consent process that occurs. The informed consent form explains the details of the study. This includes the possible risks and benefits of the treatment and treatment related procedures. The study staff will go over the study details with you and answer any questions you may have. You can take as much time as you need to make your decision. By signing the informed consent form, you are agreeing to participate in the clinical trial. If you chose to participate in a clinical trial, you may withdraw your consent at any time.

There is also an institutional review board (or IRB) that monitors the conduct of clinical trials to also ensure your rights are protected. An IRB consists of members who are not affiliated with the clinical trial you are participating in.

Where Can I Get More Information About Clinical Trials?

The National Cancer Institute/National Institutes of Health publication, Taking Part in Clinical Trials What Cancer Patients Need to Know, is a great resource. You can receive a copy or more information about cancer, cancer care and clinical trials online at www.nci.nih.gov, or call 1-800-4-CANCER (1-800-422-6237).