Are clinical trials safe?
Treatments are carefully studied by medical experts in a laboratory to determine safety and effectiveness before they advance to the clinical trial stage. Before you participate in a clinical trial, we’ll guide you through the treatment methods as well as the trial’s potential benefits and risks. Participating in clinical trials is voluntary.
Any clinical trial that involves people must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists, administrators, and members of the public. The U.S. Food and Drug Administration (FDA) requires an IRB to ensure protection of the rights and welfare of patients enrolled in clinical trials. The IRB is authorized to review, require changes to, approve, or disapprove studies.
Through a process called informed consent, you will learn about a study's treatments and tests, and possible benefits and risks, before deciding whether or not to participate.
Am I eligible to participate in a clinical trial?
Every study has guidelines for who can participate. There are many factors that may be taken into account, including type of disease, age, and gender. Ask your doctor if you are eligible to participate in any of our current cancer clinical trials. The U.S. National Institutes of Health also maintains a current list of national clinical trials online.
Do I have to pay to participate in a clinical trial?
Health insurance plans and managed care providers don’t always cover all patient care costs in a clinical trial. Coverage varies by plan and by study.
Ask a doctor, nurse or social worker from the study to help determine in advance what costs are covered. Research costs -- such as the study drug or treatment, tests, and doctor appointments -- may be covered by the study sponsor.
How do clinical trials work?
Most clinical trials progress in an orderly series of steps, called phases. This allows researchers to ask and answer questions to protect the patient and result in reliable information about the drug or treatment being tested. Clinical trials usually are classified into one of four phases:
- Phase I trials: These studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well it works. Phase II studies usually focus on a particular disease.
- Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. Participants will be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at doctors' offices and clinics nationwide.
- Phase IV trials: These also are known as Post Marketing Surveillance Trials. They involve safety surveillance and ongoing technical support of a drug after it is approved to be sold. This phase is designed to detect any rare or long-term adverse effects in a large patient population and over a longer time period than is possible during Phase I through Phase III clinical trials.