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: What Patients Need to Know (source: fda.gov).

What is Bipolar Disorder?

Bipolar disorder, also known as manic-depressive illness, is a mood disorder characterized by significant swings between mania and depression, as well as changes in sleep patterns, energy, activity, attention and impulsivity. The exact cause of bipolar disorder is unknown, but is believed to be biological.

It can be difficult to detect early bipolar disorder, and the average time from symptom onset to correct diagnosis and treatment can take as long as 8-9 years.

What is Depression?

Depression (major depressive disorder or clinical depression) is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working. To be diagnosed with depression, the symptoms must be present for at least two weeks.

What is Post Traumatic Stress Disorder or PTSD?

PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event.
It is natural to feel afraid during and after a traumatic situation. Fear triggers many split-second changes in the body to help defend against danger or to avoid it. This “fight-or-flight” response is a typical reaction meant to protect a person from harm. Nearly everyone will experience a range of reactions after trauma, yet most people recover from initial symptoms naturally. Those who continue to experience problems may be diagnosed with PTSD. People who have PTSD may feel stressed or frightened even when they are not in danger.