If you’re considering volunteering for a clinical trial, you want to make an informed decision. We’re arming you with the answers to some frequently asked questions:
Patients participating in research studies often have early access to promising investigational medications and devices, radiation therapies, and surgical techniques that offer types of care that would not otherwise be available. Patients are closely monitored for potential side effects during treatment.Learn more about the benefits
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals.
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study based on certain criteria. These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants.
For Phase I–IV research, the ideas come from pharmaceutical or device companies. For outcome or comparative effectiveness research, the ideas come from our investigators, including physicians or nurses.
In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or medication while other volunteers may receive a placebo (an inactive product) or a treatment already available.
The participant, physician and research staff may not know which volunteers receive a placebo and which receive the active treatment. This allows the physician and research staff to observe the volunteers during the study without any potential bias.
Regardless of which treatment volunteers receive, the level of medical attention and care provided is the same.
Talk with your physician or other medical provider before deciding whether to participate. Asking these questions can help you make an informed decision together:
Participants often receive a physical examination and have their medical histories reviewed by either the study physician or a research staff member once they are enrolled in the study. Their health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information.
See what participants and their families have to say about participating in a clinical trial.
Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the Institutional Review Board overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information.
This is explained in more detail in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies.
After a study phase is complete, data is collected to determine the treatment’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study.
After Phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.
If a drug is approved by the FDA, pharmaceutical companies may continue to conduct studies that compare the new medication—in terms of its safety, effectiveness and cost—to other medications already on the market or assess its long-term effectiveness and impact on quality of life.