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clinical trial
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clinical trial

In medicine, the evaluation of the effectiveness of medical treatment in a systematic fashion. Clinical trials compare new treatments with established treatments or placebos under standardized conditions. Such treatments may be drugs or surgical procedures. Ethical standards are maintained by ethics committees and they also ensure that the clinical trial procedure is explained to patients. The system was established with the development of new medicines in the 1940s and 1950s.
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Phase IV trials may be conducted by a pharmaceutical company after a product is available on the market and has received FDA approval.
Drug development research: the process by Sataloff, Robert T. / Ear, Nose and Throat Journal
Can approaches used in large phase IV trials and used by FDA inspectors be utilized?
Effective clinical study design can minimize FDA and IRB involvement: ... by Pickett, Joseph / BioResearch Compliance Report
28: Global numbers of phase IV trials 2006-2009e 155 Figure 6.
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