What are the benefits to participating in clinical trials?

 Close monitoring by the clinical staff
 Standard treatment or a new treatment
 Trial sponsors may cover costs that your insurance does not cover
 The knowledge gained from your participation in the trial could help future patients with cancer
 Potential early access to new treatment

Who is eligible to participate in a clinical trial?

 Each study has its own guidelines for who can participate, called eligibility criteria
 Participants are alike in the type of cancer that they have, age, gender, or previous treatments
 To find out if you are eligible for a study, talk to your doctor or nurse

Who pays for the patients care costs on a clinical trial?

 Even if you have health insurance, your coverage may not include some of the costs associated with the trial
 2005 Wisconsin Act 194, enacted March 24, 2006, states that no plan may exclude coverage for the cost of any routine patient care that is administered to an insured in a clinical trial if it would have been covered outside a clinical trial.
 Investigational drugs are provided without cost to clinical trial participants.
 The research team can give you a detailed sheet of what is/is not covered on the trial in which you are interested.

What are the potential risks of a clinical trial?

 New drugs and procedures may have side effects or risks unknown to the doctors
 New drugs and procedures may be ineffective, or less effective, than current approaches
 Even if a new approach has benefits, it may not work for you

How are participants protected?

 The government has a system designed to protect human research subjects
 Before a government-funded clinical trial can begin, the trial plan must be approved
 During the trial, review committees make sure that the plan is being followed and participants are protected
 Regulations require that the researchers performing studies must thoroughly inform the patients about the study's treatment and tests and their possible side effects before the patient decided whether or not to participate
 Being on a research study is completely voluntary, which means that the patient can remove themselves from the trial at anytime, as long as it is first discussed with the health care team.

What happens during a trial?

 If you decide to participate in a clinical trial, you will work with a research team.
 Team members include doctors, nurses, social workers, dieticians, and other health care professionals.
 They will monitor your care and give you specific instructions about the study.
 Participating in a trial may mean that you will have more tests and doctor visits than you would have if you were not in the study.
 The research department may also stay in contact with you after you are done with your treatment
 To make the trial results as reliable as possible, it is very important that the participants follow the research team's instructions, which includes having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.

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