News tagged with clinical trials
Related topics: patients , cancer , cancer cells , vaccine , food and drug administration
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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An experimental sleeping pill from US drug company Merck is effective at helping people fall and stay asleep, according to reviewers at the US Food and Drug Administration, which could soon approve the new drug.
Medications May 21, 2013 | 4.2 / 5 (5) | 0
The hunt for an HIV vaccine has gobbled up $8 billion in the past decade, and the failure of the most recent efficacy trial has delivered yet another setback to 26 years of efforts.
HIV & AIDS May 19, 2013 | 5 / 5 (1) | 0
Children with obstructive sleep apnea who had a common surgery to remove their tonsils and adenoids showed notable improvements in behavior, quality of life and other symptoms compared to those treated with "watchful waiting" ...
Sleep apnea May 21, 2013 | 5 / 5 (1) | 0
Italian lawmakers on Wednesday gave their final approval to a law that allows limited use of a controversial type of stem cell therapy which has been condemned by many scientists but has given hope to families of terminally-ill ...
Medical research May 22, 2013 | 5 / 5 (1) | 1