Clinical Trial Phases and their Registration in India: A Systematic Review

Abstract

The rationale behind writing this review article is to give an introduction to the clinical trial, its phases and the current scenario in clinical research in India. This article gives a brief idea about the clinical trial phases. The reader can find the process of trial in step-by-step manner with the government regulatory body that has a major role to ensure the safety of the subject involved in the experimental study, with appropriate protocol and approval of the whole experimental study. This paper describes the role of the ethics committee, the investigator and sponsors’ responsibilities along with DCGI workflow, regulations of study. This study also discusses what is CDSCO, ICH-GCP government body in clinical trials etc. The clinical trial has a crucial role in serving good health to the public and developing new promising drug candidates in the treatment of diseases. The new drug candidate and therapy enhance the quality and lifespan of the patient. Nowadays the number of clinical trials has increased in biomedical research so there is a huge need to make transparency and easy accessibility of trial studies to general people. Hence, the development of CTRI has been done. The regulatory authority strictly observes whether the guidelines are properly followed in trial or not. The regulatory guidelines are modified timely. The serious injury during trial and informed consent form are recently modified. This review article put all the essential things for the reader to get enough idea about a clinical trial in India, how it is conducted, which regulatory body involved in clinical trial etc.