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How will I know what I’m getting into, if I choose to participate in a Clinical Trial?
How will I know what to consider, before participating in a Clinical Trial?
Will I be given a Placebo (Inactive medicines) in a Clinical Trial?
How do patients pay for Clinical Trials?
After the clinical Trial ends, what happens to my personal information and results?
How do I know if I am eligible to participate in a Clinical Trial?
 
How will I know what I’m getting into, if I choose to participate in a Clinical Trial?
When patients consider participating in a clinical trial they are given an informed consent to review. In the informed consent you will learn details about a specific clinical trial so that you may decide whether you want to participate. The informed consent process is designed to make sure patients understand the clinical trial’s plan before agreeing to participate. A coordinator from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits. You will be encouraged to ask questions about any terms or anything else that may be confusing. You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.

Informed consent forms may differ but include the reason for the clinical trial which is what the researchers hope to learn. It will also state who is eligible to participate in the clinical trial. It will include what is known about the type of treatment being studied, and possible risks and benefits. Other treatments that may be options and the design (randomized, single blind, double blind, etc.) of the clinical trial will be detailed in the consent form as well. The consent will also explain the types of tests, the amount of tests, the number of study visits required and who is responsible for the costs. The consent will include a statement about protecting the patient’s privacy. There is also a statement about the clinical trial being voluntary and the patient’s rights to leave the clinical trial at any time. Consents also include all contact information for further questions.
 
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How will I know what to consider, before participating in a Clinical Trial?
Each clinical trial is unique and has its own risks and benefits.
Some possible benefits of participation:
• The trial sponsor will pay for your study related medical tests.
• You may have more treatment options.
• If the new drug or treatment works, you may be among the first to benefit.
• You may be able to help future patients with the same diagnoses.
• The comfort of knowing you would be volunteering and therefore you would be able to discontinue your participation at any time.
Some possible risks include:
• Side effects may be unexpected or worse than standard treatment side effects.
• As with standard treatment, the new treatment may not work for you even if it works for other patients.
• New treatments do not always turn out to be better than, or as good as, standard treatment
 
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Will I be given a Placebo (Inactive medicines) in a Clinical Trial?
Not all clinical trials involve the use of a placebo. A placebo is a substance that looks like medicine, but is not. Some patients are given placebos in a randomized trial only under certain circumstances. If a placebo is used, researchers may give patients in the control group a placebo that can be in combination with standard treatment. The use of a placebo would be discussed in the informed consent that you would read prior to any study related procedures.
 
 
How do patients pay for Clinical Trials?
The clinical trial sponsor may pay for the treatment, special testing, extra doctor visits, and occasionally travel time and travel expenses.
 
 
After the clinical Trial ends, what happens to my personal information and results?
Researchers identify the patients with an assigned number to protect their identities. The research team may access clinical trial information to help the study sponsor submit data to the FDA for approval but when the clinical trial results are published, patients’ names are not used.
 
 
How do I know if I am eligible to participate in a Clinical Trial?
Each clinical trial has eligibility criteria, which are requirements that patients must meet before they can participate. Eligibility criteria might include information about age, gender, past medical history and medications you have taken or are currently taking. Eligibility criteria are specific to each clinical trial.
 
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