(LifeWire) - Breast cancer is a complex condition, and new ways to treat it are always being discovered. The process of turning a promising discovery into an approved treatment always involves a clinical trial, which requires the voluntary participation of many patients. There are many reasons to participate in a trial, and many reasons not to just jump right in. Could a clinical trial be an option for you?
What Is a Clinical Trial?
A clinical trial is a research study in which a new drug or procedure is tested on humans. The treatment in question is first tested in preclinical studies -- in cells and in animals -- to determine the likelihood that it will prove safe and effective for humans.
A clinical trial is usually categorized as a phase I, II, III or IV trial. Each different phase is designed to answer a different question about the treatment, and each successive phase usually involves more people. Once all the necessary data are gathered -- usually after the completion of the phase III trial -- the US Food and Drug Administration (FDA) then decides whether or not to approve the drug or procedure for use.
Phase I trials are the first to test substances on human beings. Safety and dose of the trial drug or procedural treatment are the main objectives of these early human tests for possible future approval.
Phase II trials study trials evaluate whether the treatment is effective.
Phase III trials examine the safety and effectiveness of the trial drug or treatment in comparison with existing approved treatments. Many phase III trials include placebos and randomization (no one knows who is getting the active drug or the placebo).
Phase IV trials are typically requested by the FDA after a drug already has been approved. They usually seek to answer other questions of interest to researchers about the treatment, with more follow-up details on how it works, the exact nature of its benefit, and so on.
Why Would I Participate?
There are lots of good reasons to join a clinical trial, whether for your own benefit or for the larger goal of furthering scientific knowledge. Here are just some of the reasons you why you might want to sign up:
- The trial may give you access to a treatment that will prove to be more effective than those currently available.
- Your participation may lead to the approval of a new treatment that will help many other people.
- Many times, the trial sponsors pay for your health care, incidental expenses and for the time spent in the trial.
What Should I Know Before Signing Up?
Now that you know some of the pros, here are some of the potential cons to think about before signing up:
- You may experience unpleasant side effects, especially in the early phases of a trial.
- There is no guarantee that the treatment you receive will work for you.
- Participation may be financially complicated; researchers may not pay for your medical care and insurers may deny coverage as well.
- Your participation is voluntary. You can decide not to take part and you can decide to leave at any time after starting.
- You must, by law, be informed of all of the known benefits and risks of the new treatment. You will be required to prove that you have received and understood the benefits and risks of participating in the trial by giving your signed, informed consent.
How Can I Find a Trial That's Right for Me?
Your healthcare provider may have already recommended a trial that's appropriate and convenient for you. If not, a search of the American Cancer Society's clinical trials matching service or the National Institutes of Health clinical trials database may help you find one that interests you.
Sources:American Cancer Society Staff, "Clinical Trials: What You Need to Know." Cancer.org. 3 Aug. 2006. American Cancer Society. 23 Apr. 2008.
National Institutes of Health staff, "Understanding Clinical Trials." Clinicaltrials.gov. National Institutes of Health. 23 Apr. 2008.