What is a clinical trial?
It is a research study or a detailed and carefully controlled evaluation of a new medication, medical treatment or device.
Why are clinical trials important?
These studies are the final steps in determining the effectiveness and safety of a drug, device or treatment prior to Food and Drug Administration approval.
Are clinical trials safe?
The safety of our research is the number one priority of our staff. All aspects of each study are explained to participants in detail. If you have safety issues or concerns, our research coordinator(s) or investigator(s) will address them. In addition, an Institutional Review Board (IRB) approves all Borgess Research Institute studies. The IRB’s job is to safeguard the rights and welfare of Borgess research participants and protect them from risks. This governing body also monitors previously approved clinical trials to ensure that all participants understand the possible risks.
Who conducts clinical trials?
The principal investigator works with the subinvestigators and research coordinators to select and monitor patients.
What is a research subject?
This is someone who has volunteered to take part in a clinical trial.
How do I become eligible to be a research subject?
Before you sign up, we will talk with you about the procedures and possible risks. We will also answer your questions and make sure you are fully informed about your role. This process is called “informed consent.” Afterwards, you will be asked to sign a consent form. The form states that you understand the procedures and possible risks of those procedures.
What if I change my mind?
Research subjects can choose to withdraw from the trial at any time and for any reason. Changing your mind will not affect your medical care.
Why do patients decide to participate in clinical trials?
Patients take part for a variety reasons. Many have tried other treatment options that have not worked. Others may not have treatment options. Some discover that helping researchers learn more about their disease improves treatment for others with the same condition. Patients also find that clinical trials sometimes assist in covering medical costs.
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