When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked questions that many potential volunteers have about participating in a study.
A clinical trial is a research study in which volunteers receive
investigational treatments under the supervision of a physician and
other research professionals. These treatments are developed by
pharmaceutical and biotechnology companies who select qualified
physicians, also known as investigators, to conduct clinical trials to
determine the benefits of investigational drugs.
Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion 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. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers learn the information they need.
In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.
A placebo is an inactive product used to assess the experimental treatment's effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.
Patients considering participating in a clinical trial should talk
about it with their physicians and medical caregivers. Potential
volunteers should also understand the credentials and experience of the
staff and the facility involved in conducting the study.
Questions to ask a physician or medical caregiver:
In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' 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.
Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you. When you give written consent to participate in a clinical trial, you are acknowledging that you understand and accept all aspects of the research study-including any risks or benefits involved.
Volunteers in a clinical trial participate in the development of
medical therapies that may offer better treatments and even cures for
life-threatening and chronic diseases. However, there are risks
Possible benefits for volunteers:
Possible risks for volunteers:
Please note: volunteers may withdraw from a study at any time for any reason.
Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically 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, the data is collected to determine the drug'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, pharmaceutical companies may continue to conduct studies that compare the new drug-in terms of its safety, effectiveness, and cost-to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life.
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