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What is a clinical study?

A clinical study is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical studies (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the fastest and safest way to find treatments that work in people.

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Why participate in a clinical study?

Participants in clinical studies can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research

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Where do the ideas for studies come from?

Ideas for clinical studies usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical studies. During a study, more and more information is gained about a new treatment, its risks and how well it may or may not work.

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Who sponsors clinical studies?

Clinical studies are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). studies can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

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What is a protocol?

A protocol is a study plan on which all clinical studies are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the study; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical study, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

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What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical studies, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

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What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical studies, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

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What are the different types of clinical studies?

• Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention studies look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Screening studies test the best way to detect certain diseases or health conditions.
• Quality of Life studies (or Supportive Care studies) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

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What are the phases of clinical studies?

Clinical studies are conducted in phases. The studies at each phase have a different purpose and help scientists answer different questions:

• Phase I studies, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II studies, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV studies, post marketing studies delineate additional information including the drug's risks, benefits, and optimal uses after a treatment is already available for general use

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