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Types of Clinical Trials

Are clinical trials safe?

Who pays?



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Should You Participate in a Clinical Trial?

A clinical trial is a research study that evaluates new treatment options for patients. Based on new ideas and findings from basic research, clinical trials help physicians and scientists develop improved treatments and even cures for many medical problems. Typically conducted in hospitals, clinics or physicians' offices, clinical trials rely on patients who volunteer to try the new treatments. Yale School of Medicine supports a wide range of interdisciplinary clinical trials. For more information, visit Yale Center for Clinical Investigation or call (203) 785-3482.

What are the benefits to you?

• Possible health improvements from new treatments not available to the public
• Interaction with physicians and nurses who are at the leading edge of medical science
• Closer medical monitoring of your problem
• Satisfaction from participating in studies that may contribute to new medical knowledge and the potential of helping others with similar illnesses
• Trial often covers related costs of medical treatments

Types of Clinical Trials
Four types of clinical trials need volunteers:

Phase One: Tests a new drug's safety in the human body. A small number of volunteers are needed for this phase.

Phase Two: Tests for efficacy and dosage in several hundred patients. Often there are two groups: one receives the standard treatment or placebo, and the second receives the new treatment. Generally, costs of drugs and other medical treatments are covered.

Phase Three: Measures the drug or procedure against the best standard treatment. This is the last phase before Food and Drug Administration approval, which makes the drug available in your pharmacy. Costs are generally covered by the trial.

Equipment: Other types of trials involve testing the safety of various types of medical equipment. Generally, medical care provided through the trial is covered.

Are clinical trials safe?
Side effects and risks exist with almost any treatment, whether it is a traditional, conventional treatment or a clinical trial. However, many safeguards exist to make clinical trials as safe as possible and protect patient rights. Before a new treatment is tried with patients, it is carefully studied in the laboratory. Laboratory research establishes how best to use the new methods in people, safely and effectively.

Clinical trials must be approved by the Institutional Review Board (IRB). The IRB is a board of scientists and lay people not connected with the trial, who decide whether the trial is ethical. The IRB is also required by Yale-New Haven Hospital, Yale University School of Medicine and the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials. The IRB is authorized to review, require changes to, approve or disapprove studies. Patients who volunteer for trials can withdraw at any time without any effect on how they would be treated in the future. Trials are monitored and if obvious problems or success are noted, changes are made.

Who pays for clinical trials?
Cost is an important consideration for a patient thinking about entering a clinical trial. Clinical trials that test a treatment may require clinic or hospital visits, X-rays, blood tests or other medical procedures. Some studies may have a sponsor that pays some or all of the costs. Sponsors could be the federal government or the company that makes the new drug or device.

Health insurance and managed care providers do not always cover all patient costs in a clinical trial. Before making any decisions, you should call your insurance company to learn what its coverage would be for a specific clinical trial. In addition, at Yale-New Haven Hospital, our patient account representatives will work with you and your insurance company on reimbursement issues for clinical trials. Generally, patients do not pay out-of-pocket for participating in a clinical trial.

Last revised: Feb. 20, 2008 (jy)

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All information is intended for your general knowledge and is not a substitute for medical advice or treatment for specific medical conditions. You should seek prompt medical care for any specific health issues and consult your physician before starting a new fitness regimen.