Abstract

CLINICAL TRIAL AND IT’S PHASES - A REVIEW

*Zaware Sanika Sunil, Abhang Dhananjay Chandrakant, Dethe Sakshi Rajendra and Gholap Shubham Vasant

ABSTRACT

A clinical trial is a study of people aimed at evaluating medical, surgical, or behavioral interventions. In today`s global scientific age, clinical trials are essential to bringing new and better medicines to market. The reason for writing this review article is to provide an introduction to clinical trials, phases, regulatory approvals, their monitoring, etc. With the increasing number of clinical trials in biomedical research today, there is a great demand for transparency that allows easy access to trial research for the general public. This article describes the role of ethics committees, investigator and sponsor responsibilities, and DCGI workflow and research regulations. The research also includes CDSCO, ICH-GCP government agencies in clinical trials, and other topics. Understanding the basics of the clinical trial phase can help researchers plan and implement clinical trial protocols, thereby increasing the number of treatments marketed to patients. A scientific study that prospectively assigns participants or groups to one or more health-related interventions to assess their impact on health outcomes The influence of clinical trials extends not only to individual patients by establishing effective treatments for a limited range, but also to society as a whole by increasing the value of the health care provided. Clinical trials are tests of potential treatments in human volunteers to determine whether they should be approved for wider use in the general population.

Keywords: Clinical trial, Clinical Phases, CDSCO, monitoring, SAP, etc.