SHOULD I PARTICIPATE IN A CLINICAL TRIAL?

Category: Clinical Studies
Published on Tuesday, 05 February 2013 10:12
Written by Michael J. DiGiovanna
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Should I join a Clinical Trial?

As a volunteer in a clinical trial, you are participating in the development of medical therapies-therapies that may offer better treatments and even cures for life threatening and chronic disease. Peoples volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. or you may be suffering from a disease for which a good treatment does not currently exit. You may join a clinical trial hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study related medical care.

Whenever your reason, you may have questions anout clinical trials and drug reasearch. This pamphlet attempts to answer some of your questions. You should also ask your physician and your research center's staff any questions you may have before you volunteer. It's important that you make an informed choice about volunteering for  a clinical trial.

 

Why are clinical trials done?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments" Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previusly tested.

FOr most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the food and drug administration. FDA sets the rules to make sure that people who agree to be in studies are treated as sefely as possible.

The government requires researchers to give prospective participants complete are accurate information about what will happen during the trial.

Are Clinical trials safe?

The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide wheather to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.

Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.

What is informed consent?

Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about thestudy approach, the intervention given in the trial,he possible risks and benefits, the tests you may have.