What is a clinical trial?

A clinical trial is a type of research study designed to learn if an investigational drug, device or procedure is safe, how it works in the body, and if it works to treat a specific disease. “Investigational” means that regulatory authorities, such as the FDA in the US or the EMA in Europe, have not yet approved it for use for a particular condition, disease, or patient population.

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Without clinical trials, there would be no new medications.

Before a drug is made available to the general public, it must go through several phases of clinical research and regulatory approvals that show that it is safe and effective in treating a specific disease within the patient population that participated in the clinical trial. Most available medications are the result of past clinical research driven by patients’ unmet needs and lack of adequate treatment options. Without clinical trials and volunteer study participants, there would be no new medications.

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Why do people choose to do clinical trials?

People choose to participate in clinical trials for many different reasons, including:

• Helping others through advancing knowledge about a certain disease and potential treatment option

• Potential access to investigational treatment or drug

• Additional clinical trial related care, monitoring and tests from study doctors and nurses

It is important to note that participants may or may not directly benefit from participating in a clinical trial.