A clinical trial is a research project conducted with men, women or children to determine if an investigational drug, device or procedure is safe and effective. Some other words that describe clinical research are study, protocol, survey or experiment.
All clinical trials have guidelines about who can participate. Often, clinical trials will list medical or other conditions that must be met in order to participate in a particular study.
When you participate in a clinical trial, you can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Research is conducted in the laboratory, and often in animals, for many years before an investigational drug, device or procedure becomes available to clinical trial participants. Only the most promising new treatments make it to clinical trials, which are conducted to validate findings of this earlier research that indicated that the drug, device or procedure is safe in human participants. During the trial, physicians and medical staff will regularly and carefully monitor each participant to determine if the research is effective and safe. However, there is always some level of risk, and side effects are possible. You will be fully informed of all risks before you decide to join a study.
A clinical trial may or may not help you personally, but it will give researchers information about treating health conditions in the future. In most trials, you are randomly assigned to a control group or study group. The control group receives the currently approved medical treatment or a placebo. If it becomes clear during a clinical trial that one treatment is better than another, the trial is stopped so that all participants receive the beneficial treatment.
Each clinical trial has a well-documented plan, or protocol, about what you will need to do and what is expected. You will be fully informed about the plan and everything that is known about the benefits and risks of the research. You can ask any questions at any time. If you decide to be in the trial, you will be asked to sign an "informed consent" form.
Clinical trials vary in length. Some are as short as a few hours or as long as several years. You will be fully informed about how long you need to participate, and you may quit at any time.
Activities vary from one clinical trial to the next, but most require regular medical examinations. Some trials require taking either an approved or investigational drug, while others require a procedure. Sometimes you record information about how you are doing at home. You also may be asked to return for follow-up visits with the researcher so he or she can evaluate whether the research is effective and is safe.
Clinical trial costs are either billed to the participant’s insurance or paid by the sponsor of the study. If you do not have insurance, the costs may be paid by the sponsor.
If you agree to participate in a trial but later decide you want to drop out, you can do so at anytime, with no change in your usual care.
The information participants provide for a clinical trial is confidential. If the information from the trial is published or presented at scientific meetings, your name and other personal information will not be used. The clinical trial sponsor, as well as the U.S. Food and Drug Administration, also may review the research files and medical records.