Bipolar Research

What is clinical research?

A research study is designed to answer specific questions, sometimes about a drug or device’s safety and its effectiveness.  Being in a research study is different from being a patient.  When you are a patient, you and your personal doctor have a great deal of freedom in making decisions about your health care.  When you are a research subject, the Clinical Coordinator and the research staff will follow the rules of the research study (protocol) as closely as possible, without compromising your health.

Clinical research enables doctors and researchers to find new and better ways to understand, detect, control and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions. For example, the study might explore the best ways to treat a particular illness (one drug versus another) or how to counsel people at risk for breast cancer.

What is a protocol?

All clinical studies are based on a set of rules and procedures called a protocol. A protocol describes the overall purpose of a study and also spells out rules for including or excluding persons as participants in the study.  Additionally, the protocol determines the schedule of tests, procedures, medications, and dosages; and sets the length of the study.

What are "blind" studies?

In many clinical trials, one group of patients will be given an experimental drug or treatment, while a control group is given either a standard treatment for the illness, or a placebo (a harmless "fake" drug), or no treatment at all.

In a blind study, participants do not know whether they are getting the drug being tested, or whether they are in the control group. Sometimes, clinical trials are "double-blind" or "double-masked." That means that neither the participants, nor the study staff members know who is receiving the experimental treatment and who is in the control group receiving either a standard treatment or a placebo. Studies are performed in this way so that neither the patients' nor the doctors' expectations about the experimental drug can influence the results.

Should you volunteer for clinical studies?

Clinical studies critical to finding new treatments and cures for diseases. Carefully conducted clinical research is the fastest way to find treatments that work and that are safe. By volunteering for a clinical trial, you are participating in research that may result in a new treatment for a disease. 

Before you agree to participate in a study, you must be given complete information about the study, known as "informed consent." The informed consent must include information about the purpose of the research as well as possible benefits and risks. The Food and Drug Administration (FDA) provides details about informed consent with the information page: Clinical Trials of Medical Treatments: Why Volunteer? (source:

Participating in clinical research is an important decision, so there are many questions that you should consider before agreeing to participate. The Centers for Disease Control (CDC) has prepared a list of questions, Taking Part in Research Studies: What Questions Should You Ask? (, that can help you get the information you need to make a decision about participating.

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