Scientists develop new hydrogels for wound management

Open wounds, whether caused by accidents or from medical procedures like surgery, require proper management to speed up healing and prevent infections. While sutures and staples are common wound closure methods, they can ...

Yeast speeds discovery of medicinal compounds in plants

Cornell researchers have harnessed the power of baker's yeast to create a cost-effective and highly efficient approach for unraveling how plants synthesize medicinal compounds, and used the new method to identify key enzymes ...

Computational model helps with diabetes drug design

For diabetes patients who must give themselves frequent insulin injections, the risk of low blood sugar can be life-threatening. A potential solution is a type of engineered insulin that circulates in the body and springs ...

Mature sperm lack intact mitochondrial DNA, study finds

New research provides insight about the bedrock scientific principle that mitochondrial DNA—the distinct genetic code embedded in the organelle that serves as the powerplant of every cell in the body—is exclusively passed ...

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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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