About Clinical Trials
Whether to participate in a clinical trial is an important and personal decision. Those interested in participating in a clinical trial are encouraged to discuss this opportunity with their physician, family members, or friends before joining a trial. Trial participation is always optional, never required, and free of charge. Before making a decision, potential participants should be given information about the intervention being studied, the length of study and frequency of visits, and the required procedures. An opportunity to ask questions of an investigator should also always be provided. Only when a potential participants have this information and are confident that a trial is right for them, should they choose to enroll.
What is a clinical trial?
A clinical trial is a research study to test if an intervention helps treat or prevents disease in people. Therapies being tested in a clinical trial can be in many forms: vaccines, new pill medications, new devices, new lifestyle or behavioral changes, or new ways of using known therapies. Clinical trials are used to determine whether new therapies are both safe and effective.
After researchers test new therapies or procedures in animal studies, only the most promising laboratory results are moved into clinical trials with human participants. Clinical trials may be sponsored or funded by a variety of organizations such as the National Institutes of Health (NIH), private foundations, and pharmaceutical companies.
Who can participate in a clinical trial?
All clinical trials have specific criteria for who may participate. These inclusion and exclusion criteria help ensure safety and are vital to a trial’s scientific aims. For someone to participate in a clinical trial, they must demonstrate all of the “inclusion criteria” (e.g., be a certain age or have a specific diagnosis). They must not demonstrate any of the “exclusion criteria” (e.g. have had a stroke or have metal in their body that prevents them from having brain scans).
What are the benefits and risks?
Benefits. Well-designed and carefully executed clinical trials allow eligible participants to play an active role in their own health care. Participants may gain access to new treatments before they are widely available. Participants also obtain expert medical care at leading health care facilities. Through their participation in studies, participants are helping others by contributing to medical research.
Risks. There are risks to clinical trials such as adverse reactions to medications or the possibility that the treatment may not be effective for the participant. Some of side effects to the studies may be unpleasant, or even serious reactions. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to assure that the risks are minimized and are worth the potential benefits. Many studies require considerable time and effort, including multiple trips to the study site, extensive memory testing, or even complex dosage requirements.
What does it cost to participate?
There should never be a charge to participate in a clinical trial.
Where do the visits take place?
Most visits take place at our Clinical Translational Research Center in Hewitt Hall on the UC Irvine campus in Irvine.
How long are the visits?
On average, a visit can last 1-2 hours.
Do I need to stop taking my current medications to participate?
No, you can continue on your current medications. However, many trials require that dosages have been stable for 2 to 4 months prior to enrolling.
Will I receive feedback during the trial?
Some studies provide participants with copies of their clinical lab results, EKG tracings, and brain imaging reports.
Will I be notified about the results of the study?
Most studies provide participants with a summary of results once they are available. Studies also generally inform participants of their study assignment (study drug vs. placebo) after there is no longer risk of biasing study results.
Will there be compensation for my participation?
Some studies do provide compensation, but it varies from study to study.
Why should I participate in a clinical trial?
Most people choose to participate in clinical trials for three reasons: (1) hope to help mankind; (2) trust in the researchers; (3) hope for personal benefit. To learn more about the experiences of UCI MIND research participants, click here.
Is there a chance of getting a placebo during the trial?
In most studies, a portion (e.g., 50%) of the participants are given placebo. This varies from study to study and is critical to the scientific aims of a study.
Are there any studies that are not double-blind?
The majority of our studies are double-blind, meaning both the investigator and the participant do not know to which arm of the study the participant is assigned. On some occasions we do conduct open label studies in which all participants receive the actual study medication. These studies, however, are usually restricted to those individuals who previously completed the double-blind, placebo-controlled study of the same medication.