Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in clinical trials have an opportunity to contribute to scientists’ knowledge about new treatments and therapies. They also receive state-of-the-art care from medical experts and the potential opportunity to receive new therapy not yet available to the public.

Each clinical trial is managed by a research team that includes doctors, nurses, clinical trial coordinators, data analysts, and other specialists. The research team works closely with other health professionals, including other doctors and nurses, laboratory technicians, pharmacists, dietitians, and social workers, to provide medical and supportive care to people who take part in a clinical trial.

National and international regulations and policies have been developed to help ensure that research involving people is conducted according to strict scientific and ethical principles.  The research team at Kelsey Research Foundation, along with your physician, also monitors your care very closely.

Clinical trials are subject to regulation by the U.S. Food and Drug Administration (FDA) and must be reviewed and approved by an Institutional Review Board (IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety, and well-being of trial participants will be protected. The IRB must also review ongoing trials at least yearly and based on those reviews, can decide whether the trial should continue as initially planned or if changes should be made to improve participant protection. An IRB can stop a clinical trial if the researchers are not following the protocol or if the trial appears to be causing unexpected harm to the study participants.

Informed consent is a process through which people 1) learn the important facts about a clinical trial to help them decide whether or not to take part in it, and 2) continue to learn new information about the trial that helps them decide whether or not to continue participating in it.

During the first part of the informed consent process, people are given detailed information about a trial, including information about the purpose of the trial, the tests and other procedures that will be required, and the possible benefits and harms of taking part in the trial. Potential trial participants are given a form, called an informed consent form, which provides information about the trial in writing. People who agree to take part in the trial are asked to sign the form. However, signing this form does not mean that a person must remain in the trial. Anyone can choose to leave a trial at any time—either before it starts or at any time during the trial or during the follow-up period. It is important for people who decide to leave a trial to get information from the research team about how to leave the trial safely.

The informed consent process continues throughout a trial. If new benefits, risks, or side effects are discovered during the course of a trial, the researchers must inform the participants so they can decide whether or not they want to continue to take part in the trial. In some cases, participants who want to continue to take part in a trial may be asked to sign a new informed consent form.

Trial participants have access to promising new interventions that are generally not available outside of a clinical trial.  The intervention being studied may be more effective than standard therapy. If it is more effective, trial participants may be the first to benefit from it.  Trial participants receive regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals.  The results of the trial may help other people who need treatment in the future.  Trial participants are helping scientists learn more about a variety of diseases and conditions.

The new intervention being studied may not be better than standard therapy, or it may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy.  Trial participants may be required to make more visits to the doctor than they would if they were not in a clinical trial and/or may need to travel farther for those visits.

The costs of care for people participating in a clinical trial fall into two general categories: 1) routine care costs and 2) research costs. Routine care costs are costs associated with treating a person’s disease whether or not they are in a trial. These costs are usually covered by health insurance. Research costs are costs associated with conducting a clinical trial; these costs may include the costs of extra doctor visits, extra tests, and procedures that are required for the trial but would not be part of routine care. Research costs are usually covered by the organization that sponsors the trial.