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About clinical studies

What is a clinical study?

The aim of clinical research is to develop new medicines that help people live healthier more comfortable lives. To achieve this, researchers develop drugs that improve the treatment and prevention of diseases. Drug testing takes place in clinical studies.

During a clinical study, researchers find out whether an investigational drug is both effective in treating the disease and well tolerated.

Types of clinical studies

There are generally 4 phases of clinical research for any potential new drug. Each phase has a different purpose to help researchers answer different questions. Early phase studies (Phase 1 and 2) may look at whether a drug causes side effects, how much of the drug gets into the bloodstream, what effects the drug has on the body, and how the body processes the drug. Later phase studies (Phase 3) look at how effective the drug is in treating the condition and whether the drug is
well-tolerated for a longer period in a large population.

If a drug is proven to be effective and well-tolerated in large clinical studies, it may be approved by regulatory agencies (e.g., the FDA or the EMA) and made available to the public. Even if a drug is approved for use, it still needs to be monitored. During the final phase (Phase 4), researchers test how well the approved drug works over an even longer period of time.

The BE HEARD Study is in Phase 3.

Who is involved in clinical studies?

Clinical studies usually take place in medical clinics and/or hospitals. During a clinical study, you will be supported by a dedicated team of researchers, doctors and nurses. Each member of the study team is committed to your health and well-being. At each phase of drug development, government agencies check the results to see whether the drug can continue to the next phase.