Clinical Trials in the US & EU

A clinical trial is a carefully designed research study that is carried out with human volunteers. The trial is designed to answer specific questions concerning the effectiveness of a drug, treatment, or diagnostic method, or to improve patients' quality of life. Qualification for a clinical trial involves the selection of various desirable criteria (inclusion criteria), as well as criteria by which volunteers are rejected (exclusion criteria). Typical criteria include age, gender, the type and severity of the disease, prior treatment, and other medical conditions.

Depending on the clinical trial, the volunteers that are recruited could be healthy or ill with the disease under study. There are different types of clinical trials that make use of differing types of study plans (protocols). A treatment trial evaluates a new treatment, new drug combinations, new surgical strategies, or original radiation therapy. A prevention trial seeks to find better ways to prevent disease from occurring or prevent disease from returning. Medicines, vaccines, vitamins, and lifestyle changes can all be strong components for an avoidance trial. An analytic trial is designed to find better means of diagnosis for a particular disease or medical condition. A screening trial is designed to determine the best way to become aware of a particular disease or medical condition. Finally, a quality of life trial (supportive care trial) seeks to improve the ease and daily life of people with a chronic sickness. Clinical trials, particularly treatment and prevention trials often have several components, or stages. A typical clinical trial involves medical doctors and nurses, although social workers and other health care workers.

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