Clinical Trials: Studies of New Drugs and Medical Devices

Overview of Clinical Trials, Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials & Special Studies

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Choosing whether or not to take part in a clinical trial can be one of the toughest decisions facing a person, expecailly one who has cancer.

Clinical trials are people-based studies — as opposed to animal or lab studies -— of new drugs or procedures. Doctors use clinical trials to learn whether a new drug or treatment is safe and effective in patients. Such trials are vital to the development of new treatments for diseases, such as cancer.

The doctors in charge of the study don't know ahead of time how things will turn out. If they did, there would be no need for the study in the first place. And because the doctors don't know how things will turn out, they really can't answer the patient who asks, "Should I take part?"

Most people don't pay much attention to clinical trials until they are diagnosed with a serious illness such as cancer. You may have seen stories in the news about something going wrong in a clinical trial. The media is quick to pick up on an instance when a volunteer in a study is harmed. While it is very rare, people have been harmed, and have even died, while taking part in clinical trials. This is even more tragic when it could have been prevented. Reports of these tragic outcomes are important, because they help to expose problems in the system, which are then corrected to protect others.

What you usually don't hear about, however, are the thousands of people who are helped each year because they decided to take part in a clinical trial, not to mention the millions who ultimately benefit from others' participation in clinical trials.

There is no right or wrong choice when it comes time to decide on taking part in a clinical trial. The decision is a very personal one and depends on many factors, including the benefits and risks of the study, what the person hopes to achieve by taking part, and other preferences.

Knowing all you can about clinical trials in general — and ones you are considering in particular — can help you feel more at ease with your decision. If you do decide to participate, knowing what to look for and what to expect ahead of time can help you.

Clinical trials are conducted in all areas of medicine, including ways to prevent and diagnose diseases.

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