Clinical Trials and Clinical Research

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioural research studies, including new treatments. Clinical trials generate data on safety and efficacy. Clinical trials involving new drugs are commonly classified into four phases.  Each phase of the drug approval process is treated as a separate clinical trial which includes Pharmacodynamics and pharmacokinetics in humans, Screening for safety, Establishing the efficacy of the drug, Final confirmation of safety and efficacy, Safe guarding the quality. A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol

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