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Clinical trials: Answers to your questions
How is a clinical trial set up?
What are the benefits?
What are the drawbacks?
What information should I receive before giving my consent?

Questions to ask
Questions to ask

Before you agree to participate in a clinical trial, ask your doctor these questions:

  • What is the goal of the trial?
  • How long will it last?
  • Will I need to be hospitalized?
  • What kinds of treatments and tests will be carried out?
  • What are the treatment choices other than the one being tested in the trial?
  • How will the trial affect my daily routine?
  • How will my safety be monitored?
  • What are the risks or side effects involved?
  • Will it cost me anything to participate in the trial?
  • What kind of follow-up care will be provided?
  • What happens if I am harmed because of the trial?

When your doctor describes cancer treatment options, he or she may mention clinical trials. A clinical trial is a testing procedure that helps researchers examine the effectiveness of a new treatment. It gives patients the opportunity to receive top-quality care while participating in cutting-edge cancer research. If you’re considering taking part in a trial, here are some things you should know.

How is a clinical trial set up?

There are three types, or phases, of clinical trials. A phase-one trial is the first time a treatment will be tested on humans. The goals of this phase are:

  • to look for the best way to administer the treatment—in pill form, as a shot or as a surgical implant
  • to assess toxicity
  • to document side effects

The test group usually contains between 20 and 100 healthy people.

A phase two trial is designed to study whether the treatment actually fights cancer cells. Doctors examine the effect a treatment has on the blood and on the size and number of tumors. Because of the unknown risks and benefits, a limited number of cancer patients are involved—usually a few hundred.

By the time a trial reaches phase three, researchers have assessed its benefits, side effects and effectiveness. This last stage compares the new treatment with a standard one. Factors such as survival rate and side effects are measured to determine if the new treatment is better than or equal to the traditional one. Phase-three trials often involve several hundred or thousand patients.

What are the benefits?

Besides the possibility of receiving a breakthrough treatment that is more effective than a standard method, trial participants receive high-quality healthcare from experts in the field. They are also contributing to a study that could potentially help many other people. Finally, they can rest assured that they are taking an active role in their treatment.

What are the drawbacks?

Some treatments aren’t necessarily as good as the standard ones, and unexpected side effects could occur. Because you’ll be closely monitored, you may have more tests to undergo and more paperwork and logs to fill out compared to patients receiving standard treatment.

Although two recent studies found that the cost of caring for trial patients is not much higher than that for patients receiving standard care, talk to your insurance company first. If it won’t cover your trial expenses, the study could prove personally costly.

What information should I receive before giving my consent?

Nothing about the trial you are about to undertake should be considered confidential. The trial will follow a specific scientific protocol that outlines the purpose of the study as well as approval by a review committee.

Before you give your consent you must be given all available information about the study. Signing the consent form doesn’t mean you can’t leave the study. You may leave at any time without penalty.