Patients

What is a clinical trial?

The purpose of healthcare research in human participants is to improve the care of patients at all stages of disease. Clinical trials are a key step in the process of developing a healthcare product. They aim to establish and evaluate the safety and efficacy of new treatments.

Clinical trials are designed and managed according to strict scientific, legal, regulatory and methodological standards, and are governed by medical ethics. Clinical trials are conducted after preclinical “in vitro” and “in vivo” studies have been completed, and can only be initiated after authorization from health authorities and regulatory bodies, which are closely involved in clinical trial design.

Health authorities deliver market authorization to each healthcare product. The results of clinical trials provide the basis for the healthcare product to become registered.

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Preclinical

In vitro and In vivo studies
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Phase I

Evaluate safety and determine safe dosage
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Phase II

Assess efficacy and further safety evaluation
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Phase iii

Confirm clinical efficacy and safety, monitor adverse events and compare to other treatments
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Phase IV

Provide additional information after approval, monitor long term effectiveness and safety in the general population
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