Clinical Trials

Clinical trials also known as clinical research studies that follow a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.

Clinical trials for the development of new drugs are and their most part initiated and financed by industry. There are also many clinical trials initiated by academic clinical researchers. Whether initiated by industry or by academic clinical investigators clinical research is often performed in national, European and worldwide consortia, which can sometimes, be very large ones. Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. As a consequence, clinical research is highly regulated. To facilitate collaborations across borders, many aspects of this regulation are harmonized at the European level but also worldwide.

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