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Clinical Trials: A Brief Review

Sagade Vaibhav, Kamble H, Bhusari Vishwas M, Andhale Ashwini3


Clinical trials, according to the World Health Organization, are used to test new medicinal entities on humans after they have been studied in animals. Clinical studies are usually divided into five stages. Clinical pharmacologists study phase I pharmacokinetics, safety, and gross effects on human volunteers. If the drug passes the test, it moves on to phase II testing, where pharmacokinetics, safety, and therapeutic efficiency are studied on a small number of patients by clinical pharmacologists. If the test passes, hundreds of patients are studied by clinical investigators in phase III, primarily for safety and therapeutic effectiveness. If this passes, the medicine is now approved and available for sale. Even after the drug has been commercialized, physicians from numerous hospitals and clinics have sent their feedback on the drug, including ADR and efficacy in phase IV. The aim of this review paper is to compile the information regarding preclinical trials and clinical trial with future of the same.


Clinical Trial, Pre-clinical, Phases, NDA, ICH, GCP.

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