Clinical Trials: a Guide

What Is a Clinical Trial?

It’s when a team of scientists and doctors tries a new medical treatment, drug, device, or method on a group of people to test how well it works. The purpose of a clinical trial is to find a new and improved way to treat, prevent, or diagnose different types of illness.

In many cases the trial might be for something that is not yet available to the general population of people with an illness. Special allowances are made so doctors can learn more about how well a new approach works. They test the results against the best available current treatments with the goal of finding something better.

This could be especially useful if you have a serious illness and have run out of effective standard treatments.

Scientists first test these new treatments with laboratory experiments. Next, they try them on laboratory animals. Only when they deem them safe and useful enough in these early stages does a clinical trial start on people -- first in small groups and then in larger ones.

Clinical trials help doctors discover the answers to these questions:

• Is the treatment safe and effective?
• How well does the treatment work?
• Is the treatment potentially better than the treatments we have now?
• What are the side effects and risks of the treatment?

Phases of a Clinical Trial

There are several stages, or “phases,” of a clinical trial. Each new phase builds on information from previous stages.

You might qualify for a certain phase of a trial because of the state of your health or the seriousness of your particular illness. People who take part usually do it in phase III or IV of the trial.

Could Any Problems Arise From a Clinical Trial Treatment?

Almost all treatments carry some risk. The amount will depend on the type of treatment and on your general health.

In general, scientists don’t know as much about how clinical trial treatments affect your body. So there may be more risk of unknown side effects than with already established treatments.

What Is Informed Consent?

The doctors and nurses doing the trial will explain the treatment to you, including its possible benefits and risks, and then ask you sign a release form that gives your consent to take part. This is your “informed consent.”

Keep in mind that your signature does not bind you to the study. You can decide to leave the trial at any time and for any reason.

In addition, the informed consent process is ongoing. After you agree to a clinical trial, your medical team should continue to update you with any new information about your treatment that might affect your willingness to stay in the trial.

Who Can Take Part in a Clinical Trial?

A trial is typically for a certain condition, and each phase might require a different level of symptoms. If you fit the guidelines for a trial, you may be able to participate. Sometimes you might need certain tests to confirm that you’re a good candidate.

Your personal information is confidential and not attached to your name in the study.

Important Questions to Ask

If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to join. Here are some important questions to ask:

1. What is the purpose of the clinical trial?
2. What kinds of tests and treatments does the clinical trial involve, and how are these tests given?
3. What is likely to happen in my case with, or without, this new research treatment? (Are there standard treatments for my case, and how does the study compare with them?)
4. How could the clinical trial affect my daily life?
5. What side effects can I expect from the clinical trial? (Note: There can also be side effects from standard treatments and unpleasant effects from the disease itself.)
6. How long will the clinical trial last?
7. Will the clinical trial require extra time on my part?
8. Will I have to be hospitalized? If so, how often and for how long?
9. If I agree to withdraw from the clinical trial, will my care be affected? Will I need to change doctors?

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