News tagged with clinical trials

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

'Low T' therapy has yet to be proven: FDA

(HealthDay)—Testosterone supplements have long been marketed to aging men as a fountain of youth and virility, but there is still no proof they are safe or effective, according to the U.S. Food and Drug Administration.

Aug 20, 2015
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Engineering better drug delivery

Tom Dziubla, Gill Associate Professor in the Department of Chemical and Materials Engineering at the University of Kentucky, studies antioxidant polymers, working to answer the question, "Can we take a material and develop ...

Aug 18, 2015
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Regenerating nerve tissue in spinal cord injuries

Researchers at Rush University Medical Center are exploring a new therapy using stem cells to treat spinal cord injuries within the first 14 to 30 days of injury. Rush is only the second center in the country currently studying ...

Aug 13, 2015
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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

This text uses material from Wikipedia, licensed under CC BY-SA

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