What are Clinical TrialsJune 10, 2013 2013-06-10 9:48
What are Clinical Trials
What are Clinical Trials :- Clinical trials experiment includes sequence of tests integrated in therapeutic research and new drug development that helps produce safety and efficacy information (or more purposely, data pertaining to adverse drug reactions and adverse effects of novel interventions) for treatment measures (e.g., therapeutic drugs, medical diagnostics, health care devices, therapy protocols). They will be put to use only after adequate information has been gathered on the integrity of the nonclinical safety i.e. testing on animals, and applicable regulatory /ethics committee approval is granted in the country where approval of the drug or device is compulsory. Previously, many developing countries did not necessitate local trials for new product/drug approvals. Now, though developing countries still acknowledge new drug trial data from U.S./Europe, they are still pressing the need for some local trial assessments.
Basing on the nature of drug and the phase of its development, clinicians initially engage volunteers and/or patients into pilot trial projects, and subsequently conduct broader scale research in patients that often weigh against the new drug with pre-existing drugs for the problem of interest. As efficacy and safety of novel drug data are collected, the number of patients is normally increased. Drug trail experimentation can vary in size, and can comprise of a single participant in one nation or many such participants in multiple nations.
A good trial conduct may include considerable cost, and the force of paying all the necessary people involved and services is usually carried by company/entity commonly called sponsor, which may be a government body or a medical device manufacturing company or a drug discovery company. When the required support tasks exceed the resources of the sponsor, a clinical trial will be conducted by an outsourced party, namely a contracted research organization (CRO) or a research entity in an educational institution.
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