Frequently Asked Questions
- What is a clinical trial?
A clinical trial is a research study involving volunteers, which attempts to answer scientific questions regarding the safety and effectiveness of new treatments, or compares new treatments to current standard treatments. Clinical trials are the only real means to determine if a new treatment is safe and effective in humans. Prior to clinical trials with humans, new treatments go through extensive testing in the laboratory and in animal studies.
- Who approves the clinical trials that are being conducted?
The Food and Drug Administration must give their approval before experimental treatments can be used in any clinical trial. Here at USC, new studies must also be approved by the Institutional Review Board (IRB) prior to being conducted. The IRB is a committee made up of doctors, scientists, pharmacists, nurses, clinicians, and members of the local community. It is their task to make sure that studies are ethical, well thought out, and that risks to volunteers are minimized.
- Who participates in clinical trials?
People choose to participate in a clinical trial for a variety of reasons. Some people volunteer in order to have access to the latest alternative treatments. Some hope that their participation will benefit others who are infected with HIV. Still others seek the additional care that is often part of a clinical trial, where subjects are closely monitored.
- Are there benefits? Are there risks?
You may or may not benefit from being in a research study. No one can tell for sure. There are risks and side effects in virtually any clinical trial. Ask the research staff about the specific risks and side effects in the study you are interested in.
- Who covers the cost of participating in a clinical trial?
Most costs for experimental treatments, lab tests, and other study related procedures are paid for by the study. Costs for procedures or laboratory tests not related to the particular study may be covered by other sources, such as private medical insurance or other programs.
- What is Informed Consent?
Prior to entering a study, subjects go through a process called informed consent. This is the process where a subject is given information about the particular study; things like why it is being conducted, what experimental treatment is being used, possible risks and side effects, potential benefits, number of study visits and lab tests required, etc. This is also the time when prospective subjects ask the provider questions so that they can fully understand all aspects of the particular clinical trial. Subjects are encouraged to discuss study participation with their family, friends, or primary care physician before deciding to make the important decision about whether to be in a study or not.
- Can you change your mind about being in a clinical trial?
Yes. Subjects can decide to not participate or stop participating in a clinical trial at any time without affecting their health care or benefits. Just let your provider know.
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