Clinical trial
Author(s):
Shreya .V.Patil, Tanushri.J.Patil, Parimal.S.Jadhav, Sayali.S.Patil
Keywords:
Types of clinical trials, phases, guidelines, Protocol, Importance, Ethics Committee and Regulations
Abstract
This review article provides an introduction to clinical trials in India, focusing on their phases and current scenario. It provides a step-by-step guide on the process, including the role of the ethics committee, investigator, and sponsors, as well as DCGI workflow and study regulations. The article also discusses the involvement of the CDSCO, ICH-GCP government body in clinical trials. Clinical trials play a crucial role in providing good health to the public and developing new drug candidates for disease treatment. The development of Clinical Trial Regulation (CTRI) has been implemented to ensure proper follow-up of guidelines and to update serious injury during trial and informed consent forms. This review article provides essential information for readers to understand clinical trials in India, their conduct, and the regulatory bodies involved. Clinical trials minimizes bias and maximizes treatment effect estimates within budget. Over-collecting data may reduce recruitment and lead to bias. Administration mode affects data quality, cost, and completeness. Design features improve data completeness, but further research is needed to evaluate strategies. Theory-based guidelines for self-administered questionnaires are proposed but require evaluation.
Article Details
Unique Paper ID: 161847

Publication Volume & Issue: Volume 10, Issue 6

Page(s): 349 - 354
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