What is a Clinical Trial ?
A clinical trial is a way new experimental medications are tested in limited groups of persons for safety and efficacy before they are approved by the FDA. The term “Study” is sometimes also used since a clinical trial studies an experimental medication.
Why should I participate?
Here are some of the reasons to participate:The treatment being studied may work for you.Clinical trials may be the only way to get a promising new treatment.Study drugs are usually free.You may help speed the development of new treatments.
What if I get ill from taking the drug?
Most clinical trials are designed so if a patient becomes ill from a drug , they may be switch to a lower dose, temporarily stop the drug or be taken off drug completely. In some studies they may be switched to another drug . It is up to the patient to keep in close contact with their doctor and report any changes in their health so that he may be able to treat any side effects as soon as possible.
Is there a chance I might get a fake drug?
Placebos or “fake drugs” are used to see if the new experimental drug is more effective than no medication and to check for side effects. The only way to prove the effectiveness of a new medication is to test it against a placebo.
What is expected of me if I participate in a clinical trial?
Be honest about your medical history, and you will probably be asked to provide some medical records from your primary care physician to make sure you qualify for the particular study your interested in, and wont be endangering your health.Follow instructions and take study drugs as recommended.Keep appointments or re-schedule them at least 24 hours in advance.Report any changes in your health.
What should I expect from the center conducting the study?
Be told all important details about your care.That if you ask a question you have it answered in a way that you can understand.That you have a right to refuse any test, procedure, or medication if you so wish.Get a second opinion from any other health care provider you wish, if in doubt about any part of the study.Know that your medical records will be kept confidential.
What information should I know before I sign the Informed Consent?
Before you sign the consent form, you should know:the reasons why you would be using the drugthe risks and benefits of taking the drug the length of the studyinformation covered in the informed consent