News tagged with clinical trials

Related topics: patients , cancer , cancer cells , vaccine , food and drug administration

Justice Department says Shire will pay $56.5M fine

The U.S. Department of Justice said Wednesday that Irish drugmaker Shire will pay $56.5 million to settle allegations it broke the law in promoting five different drugs, including its attention deficit disorder drugs Adderall ...

Sep 24, 2014
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Clinical trial

In clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be the pharmaceutical or biotechnology company that developed the agent under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization

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