Patient Guide to Clinical Trials

What are Clinical Trials?

A clinical trial usually is the study of a new drug, medical device, health related treatment or medical diagnostic method in people. These clinical trials, or studies as they are sometimes called, are done only after much safety testing in animals and human cells. Clinical trials sponsored by companies are first reviewed and approved by the U.S. Food and Drug Administration (FDA). Some studies test new drugs or treatments and others answer additional questions after a drug or treatment is approved by the FDA.

There are four main types of clinical trials:

Phase 1: This is the first study that involves using humans to test dosage and safety of a medication such as a drug. Usually not more than a few doses are given and the study typically involves a small number of people.

Phase 2: This phase will often treat a small number of patients for a longer period of time. It is used to evaluate the safety and dosing in patients with the disease of interest.

Phase 3: This phase proves a new drug’s safety and effectiveness. It often involves many research centers, a larger number of patients and sometimes a longer treatment and/or follow-up period.

Phase 4: This type of study is done after the FDA has approved a drug and is used to confirm the benefit and risks of a drug or test new uses.

What are the Benefits and Risks of Entering a Clinical Trial?

The benefits from participating in clinical trials include:

  • you will be evaluated by doctors and nurses at frequent intervals for free which may improve your chances of getting better,
  • you will learn more about your disease by participating in a clinical trial,
  • you will help others by contributing to develop important new medical products, and,
  • in some clinical trials, you may be compensated for your time.

The risks versus benefits vary depending on the product.  For example, a lifesaving therapy for cancer may have significant side effects while a therapy for headaches should only have very minor side effects. Before you enroll in a clinical trial, the doctor will tell you all of the known side effects and benefits of the therapy so you can make an informed decision.

Without volunteers for clinical trials there would be no advances in new treatments. You can play an important role in the future of health care.

Courtesy of Patient Recruiters International

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