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A research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals.

These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

Clinical trials are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy, or procedures to improve the diagnosis of disease and the quality of life of the patient.

Some benefits of a clinical trial are that it provides an opportunity for patients to be involved in their own healthcare and receive more personalized care.

In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.

None of the existing treatments result in a cure for all patients, nor are they without side effects, and doctors continue looking for better ways to treat the disease.

Clinical trials are also organized into different phases of research, in order to build up a greater understanding of the new treatment, before it is approved or recommended for routine use.

Phase I – the first studies in humans are Phase I trials. They are performed with small numbers of patients or healthy volunteers and are used to answer questions such as what dose of the drug is likely to be effective and what side effects might occur.

Phase II – these trials continue this process with larger numbers of patients. They have a greater focus on how well the treatment or procedure works, perhaps in particular situations or groups of patients.

Phase III – these trials enroll large numbers of patients and are used to compare the effectiveness and safety of the new treatment with that of the standard existing treatment. Information obtained from large Phase III trials that demonstrate the benefits of a new drug over the existing treatments are sometimes presented to regulatory authorities in order to obtain a license to market and sell the drug.

Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of the study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.

If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.