A clinical trial is a study to evaluate one or more treatments. Clinical trials are a standard research practice and are done on all medications before they are approved by the Food and Drug Administration. Some trials evaluate the effects of new or existing treatments. Some may study new forms of psychotherapy (talk therapy). Others may study a combination of therapies. Clinical trials are most often conducted by universities but may also be conducted by government agencies or private companies. Many trials are funded by pharmaceutical company grants. All participants are volunteers.
It is important to understand that the objective of a clinical trial is research, not patient care. This does not suggest that trials are designed to harm people—in fact they are carefully designed with patient safety in mind. However, individuals participating in the trial cannot be guaranteed of receiving any new treatments. Some individuals may not receive any treatment at all. The contribution made by participating in a clinical trial is to science first and to the patient second.
More About Clinical Trials
In a typical clinical trial evaluating medications, one group receives a new treatment. A second control group receives a treatment already in use. In some trials, another group will receive a placebo, a sugar pill that has no medicine in it. Most times participants do not know which they are receiving.
Other clinical trials involve a crossover design, where participants are randomly assigned to take a new treatment, a treatment already in use, and/or a placebo for a specified time period. When that portion of the study ends, participants cross over to one of the remaining treatments for another specified time period.
In trials that test new forms of psychotherapy, one group may be randomly assigned to a new form of therapy and another group may receive a standard method of psychotherapy or a combination of psychotherapy and medication. (back)
Any decision to participate in a clinical trial should be made after discussing the pros and cons with your doctor. People participate in clinical trials for a variety of reasons:
Treatment during a clinical trial almost always follows a protocol, a step-by-step set of instructions about how and when participants receive treatments. This protocol will usually control doses of medication, number and timing of visits, and any adjustments to treatment. (back)
Admission into a clinical trial is based on a rigid set of requirements.
Every clinical trial involves a trade-off. Remember that any decision to participate in a clinical trial should be made in consultation with your doctor.
Some Drawbacks of Participation
Before agreeing to participate in a clinical trial, ask questions. Understand the study's protocol--the plan to be followed. It's crucial you feel comfortable with the protocol because, to protect the scientific integrity of a trial, straying from protocol is seldom allowed. Be sure you completely understand what is involved in the study before you begin. Do not be afraid to ask questions before you begin or anytime during the trial.
Questions to ask include:
First, ask your physician of clinical trials that relate to your illness. Research organizations conduct clinical trials in most cities. Some trials are listed on DBSAlliance.org and on We Search Together.
All clinical trials should be publicly registered, and many are registered at www.clinicaltrials.gov. This site lets you search for clinical trials, get basic information about trials, and learn who to contact for more information.
For another source, call the Office of Public Inquiries at the National Institute of Mental Health (NIMH), (301) 443-4513, or visit NIMH's web site.
Ads for clinical trials appear in newspapers, magazines, on billboards, the radio and television. These ads usually do not adequately describe the trials, but usually give you contact information. Be sure to review possible risks and benefits with your doctor, family and friends before participating in any trial.
Depression and Bipolar Support Alliance does not endorse nor recommend any particular clinical trial. Patients should discuss all options with their health care providers and family members before beginning any trial. (top)
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