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Clinical Trials

Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, devices or new ways of using known interventions), generating safety and efficacy data. They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought. Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.