Genetics

Gene therapy blocks peripheral nerve damage in mice

Nerve axons serve as the wiring of the nervous system, sending electrical signals that control movement and sense of touch. When axons are damaged, whether by injury or as a side effect of certain drugs, a program is triggered ...

Health

Herbal antioxidants are becoming increasingly important

The human body is constantly exposed to so-called free radicals, which are a burden on the body. If they get out of hand, the result is oxidative stress, which can promote disease. While this has been treated in the past ...

Cancer

Personalized treatment benefits kidney cancer patients

Personalized treatment plans may extend life expectancy for early-stage kidney cancer patients who have risk factors for worsening kidney disease, according to a new study published in the journal Radiology.

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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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