Abstract

A COMPREHENSIVE REVIEW ON CLINICAL TRIALS

Dhananjay Narsale*, Hemant Kamble and Santosh Waghmare

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Abstract

A clinical trial is a type of research that looks at specific health issues with human volunteers. The quickest and safest way to find a treatment that works for people and a way to improve health is through carefully conducted clinical trials. Under controlled conditions, investigational trials determine whether experimental treatments or new ways to use known therapies are safe and effective. Health issues are addressed in large populations or natural populations through observational trials. A crucial and highly specialized type of biological assay, clinical trials aim to measure therapeutic efficacy. Clinical pharmacologists conduct research on human volunteers for phase I pharmacokinetics, safety, and gross effects. If the drug passes the test, it moves on to phase II testing, where clinical pharmacologists study the pharmacokinetics, safety, and therapeutic efficacy of selected patients. If the drug passes, clinical investigators now study hundreds of selected patients in phase III, primarily for safety and therapeutic efficacy. The drug is now approved and can be sold if this is passed. Physicians from a variety of hospitals and clinics still provide feedback on the drug's efficacy, ADR, and marketing after phase IV.

Keywords: Clinical trials, Phases of clinical trials, ICH guidelines, IND, NDA.