News tagged with clinical trials

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

Circadian clock-Angelman syndrome link established

Monitoring participants' biological clocks may be the quickest way to determine the effectiveness of experimental drugs currently under development to treat Angelman syndrome: a debilitating genetic disorder ...

Feb 05, 2015
popularity 69 comments 0

Stopping HIV in its tracks

Is the end of HIV near? Findings published this week in Antimicrobial Agents and Chemotherapy report that a novel, subdermal implant delivering potent antiretroviral (ARV) drugs shows extreme promise in sto ...

Apr 28, 2015
popularity 679 comments 1

Turning the tables on cancer

In the spring of 2012, Tom Stutz was a man without a future. Just getting through the day took all of his energy and determination.

Jun 29, 2015
popularity 166 comments 0

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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