What are clinical trials?

A clinical trial is a form of medical research that centers on patients. These carefully planned, scientific studies help doctors select the safest, most effective approaches to cancer treatment. Most of the current techniques for treating cancer as well as other major illnesses have been developed using clinical trials. The information gathered helps doctors determine what is sometimes called “the standard” for medical treatment. According to the National Institutes of Health, clinical trials remain a key activity for improving healthcare.

The majority of clinical trials are designed to identify the effects of specific treatments on patients and their illnesses. Trials, also called research protocols, examine the outcomes of the treatments and compare the effects of one treatment with those of another. Usually, a clinical trial takes place because several different treatments seem promising. No one can know which works best until the trial is completed. Remember that before any treatment becomes part of a clinical trial, it undergoes careful evaluation in the laboratory, including testing in animals for both safety and effectiveness. Only the most promising treatments are ever given to people.

There are many different types of clinical trials, and each is designed to answer specific questions. Some test whether certain treatments should be combined others look at ways to help people with cancer live better lives. The latest medical advances and the most up to date treatments are often connected with trials. In addition, trials closely monitor the patient’s disease and well being, along with any side effects.

For a patient, there can be advantages to being in a trial. Starting at a specific point in each person’s illness, the trial follows the patients’ progress for a given period into the future. Each trial looks at a group of patients. No cancer treatment tested in a clinical trial can be certain to benefit a particular patient.

All people being treated for cancer should get the best available treatment, whether or not they are in a trial. Choosing the best medical treatment calls for finding out about technical information that may be new to you. The decision to enter a trial is yours. Speak with your physician. Take the information you obtain and discuss it with family members and trusted friends.

Cancer treatments have improved. Today, millions of people who are diagnosed with cancer survive and continue to lead active, productive lives. When you think about cancer, remember that every person is different and that new treatments are changing the outlook for cancer patients. Some patients can be cured, and often patients live longer and more fully than ever before.

How can my participation in a clinical trial help me?

Being part of a clinical trial may help a patient in several ways:

  • New, experimental treatments are available to you only if you are enrolled in a clinical trial.
  • Physicians and nurses monitor your health closely. They also watch you very carefully for any side effects and changes in your condition you may experience while in a clinical trials.
  • Physicians running a trial carefully monitor medical advances. For example, if new treatments are shown to be better, you are informed. Sometimes, a trial changes in midcourse, and a new and different treatment is added. In this way, you are able to benefit from new treatments as soon as their value has been proven.
  • You may get part of your treatment free of charge.
  • Some patient advocates feel that more people with cancer should be given the chance to participate in a trial. The National Cancer Institute agrees and is trying to open trials to more people.
  • Because physicians and researchers learn from each and every clinical trial, your involvement may ultimately help other people.
  • Many people take part in clinical trials because they might be cured, can get excellent care, may live longer, and, it is hoped, will enjoy life more. While not without risk of side effects, trials offer both hope and help.

How do I know if I am eligible to become a part of a clinical trial?

Each trial is designed to answer certain questions. All aspects of a particular treatment cannot be studied in one single trial.

Worthwhile information can come of at the end of a trial only if the right information goes in at the beginning. For example, a trial may be open only to patients with a particular type of cancer or only to people who have not yet received any therapy or only to those whose cancers have been in place longer and who have had some prior treatments. Only people who are the “right fit” are eligible for a particular clinical trial.

After cancer is diagnosed, tests are performed. There are many types of tests doctors can run, and each patient receives only some of these. Ask your physician and nurse about the tests you will be given.

The results of these tests help your doctor determine the “state” of your cancer. Put simply, the doctor finds out if the cancer is in the beginning, middle, or an advanced stage. For example, some cancers that are in a beginning stage are found only in one tiny part of the body; other cancers that are in an advanced stage are found in several parts of the body. Of course, the physician’s analysis and definitions are more detailed than described here. Once the cancer stage has been classified, you will be told which trials are open to you.

What is informed consent?

If you wish to join a clinical trial, you will be asked to sign an informed consent form. Some patients sign this even though they do not know enough about the trial.

Informed consent involves more than just signing a piece of paper. “Informed” means to have a specific kind of information or knowledge. “Consent” means to agree, Informed consent means you understand something and agree based upon careful review of this information or knowledge.

Make sure you understand what the trial involves before you agree to enter it. What will happen to you if you are in the study? What are the goals of the study? What are the risks? The trial should be explained to you in language that is clear and simple.

Sign the form only if you truly understand the clinical trial; understand why you will or will not be in it; and want to participate.

The United States government has rules on informed consent. Many states also have such rules. The rules say that people who conduct studies must provide patients with all the information they need to make decisions in their best interest.

If you do enroll in a trial, remember that informed consent should be a process that continues. What you know and understand about the trial should grow as new information is gathered. Physicians and nurses should keep you up to date and should answer your questions. At any time, you may say that you wish to withdraw from a trial without penalty.

What are my legal rights?

Specific laws protect your safety and rights if you enroll in a clinical trial. The laws that apply vary. Some are United States government laws, some are state laws.

By law, you have the right to know what is going to happen to you. You also have the right to drop out of a clinical trial at any time. However, it is usually not wise to do so without talking with your physician to find out if you should receive some type of treatment.