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Clinical Research FAQsHow is a drug approved for testing?The Food and Drug Administration must authorize a drug company’s proposal to do research studies. Once the studies have been completed, the FDA must review the information for safety and efficacy to determine if the drug works. This process may take many years. Who can be in a research study?The FDA has very strict requirements on the inclusion and exclusion criteria for research studies. This means that a patient has to meet the FDA criteria before being entered into the trial. There are also risks in participating in studies with new drugs. Your physician should review these risk with you to make sure you are comfortable with the study. You can learn more about the clinical trial process by visiting the FDA's website.
What is an Informed Consent?This consent must be obtained before any research procedures are done. It is a process designed to give volunteers the information they need to decide about participating in a research study. It allows the volunteer to ask questions and exchange information freely with the investigator. What is an Institutional Review Board (IRB)?It is a group of healthcare specialists that must review and approve a research study before it begins. It also monitors the study conduct throughout the duration of the study. It’s primary responsibility is to protect the safety and rights of study participants.
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