Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all United States-based clinical trials must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called “phases.” This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:
In addition, after a treatment has been approved and is being commercially marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
No. If you qualify and are chosen to participate, you will receive all study-related care, including investigational study drug, at no cost to you.
Informed consent is one of many safeguards in place to ensure patient protection. The federal government regulates most clinical research. All researchers prepare plans of action for their studies, called a “protocol.” The protocol outlines how many people will take part in the study, what medical tests they will receive and how often, as well as the treatment plan. The same protocol is used by every doctor who takes part in the study.
Before a study can proceed, its protocol must be reviewed and approved by the University of California, San Diego Institutional Review Board, which includes doctors, ethicists and members of the community. They ensure that the trial is safe and does not pose unethical risks to patients.
Clinical trials take place in the same setting where standard patient care occurs. Doctors, nurses, social workers and other health professionals are often part of the team that cares for you. As a clinical trial participant, you may have more tests and office visits than patients following standard treatments. In addition to the treatment schedule prescribed by your physician, you may have other responsibilities, such as keeping a log or filling out forms about your health. Some studies continue to follow up with patients after treatment is over.
In addition to your doctor and nurse you will have a clinical research study coordinator to help you through the clinical trial. This individual will schedule appointments, make sure your labs are performed, ensure your visits go well, and will be on call for all questions relating to the trial.
You can leave a clinical trial at any time and for any reason.