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  3. CLINICAL TRIALS: AN OVERVIEW
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Mr. Shubham Vitthal Tanpure1, Ms. Archana Gawade2

CLINICAL TRIALS: AN OVERVIEW

A clinical trial is a research project using human participants to address certain health-related problems. Clinical trials are the quickest and safest approach to discover treatments that benefit patients and ways to enhance health. Investigational studies examine the safety and efficacy of novel applications of conventional therapy in a controlled setting. Observational trials examine health concerns in sizable populations or groups of people in their natural environments. Clinical trials are a significant and highly specialized type of biological experiment that are used to evaluate the efficacy of treatments1. Clinical pharmacologists study the phase I pharmacokinetics, safety, and gross effects on human volunteers. If the drug passes the test, it moves on to phase II testing, where clinical pharmacologists study the pharmacokinetics, safety, and therapeutic efficacy of the drug on a small group of patients. If the test is successful, hundreds of small-group patients are now studied in phase III, primarily for safety and therapeutic efficacy. If it is authorized, the medication can now be sold. Even after the drug has been marketed, doctors from various hospitals and clinics provide their feedback on the medication, including any adverse events and phase IV effectiveness