What is clinical trialJune 8, 2013 2013-06-08 22:00
What is clinical trial
What is clinical trial :- Clinical trial conduct includes series of tests included in medical research and drug development that help generate safety and efficacy data (or more purposely, information pertaining to adverse drug reactions and adverse effects of new treatments) for treatment procedures (e.g., drugs, diagnostics, devices, therapy protocols). They are takenup only after satisfactory information has been collected on the quality of the nonclinical safety i.e testing on animals, and regulatory authority/clinical ethics committee approval is granted/approved in the country where approval of the drug or medical device is required. Previously, many developing countries did not necessitate local trials for new product/drug approvals. Now, though growing nations still accept details from U.S./Europe, they are still insisting on need for some local trial assessments.
Depending on the type of drug and the stage of its development stage, physicians initially recruite volunteers and/or ill subjects/patients into small pilot trials, and consequently conduct larger scale research in ill subjects/patients that often compare the new drug with others already approved for the problem of interest. As safety and effectiveness of new drug data are collected, the number of ill subjects/patients is typically increased. Clinical trail experiment can vary in size, and can include a single stake holder in one nation or many such stake holders in multiple nations.
A proper conduct of a clinical trial may include substantial cost, and the pressure of paying for all the necessary people and services is usually carried by the sponsor, which may be a government body or a drug discovery company or a medical device manufacturing company. When the variety of required support tasks surpasses the resources of the sponsor, a clinical trial will be handled by an outsourced party, such as contracted research oganization (CRO) or a research unit in an educational institution.
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