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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

ABC of Clinical Trials with the Mark of Safety, Efficacy and Transparency

Author(s): Manisha Saini, Swagat Tripathy*, P N Murthy, B P Partra, Harish Dureja and Rakesh Godhani

Volume 4 , Issue 2 , 2017

Page: [120 - 127] Pages: 8

DOI: 10.2174/2213476X04666170717103612

Price: $65

Abstract

Background: “Trial “and “Clinical” emanate from the Anglo–French trier and from the French cliniqu´e and from the Greek klinike respectively; which denotes to try and to the practice of taking care of the sick at the at the bedside.

Discussion: Therefore, a clinical trial is the summation of activities or process of positioning something to a test. It’s finally to validate whether said drugs is for the worth of treatment or for prevention and or cure of disease or sickness or not. So any new drug or new medical devices need to pass through several stages of clinical trials along with animal studies before stepping into market primarily to anchor safety, efficacy.

Conclusion: This article comprises a brief, however, a revealing basics of clinical trials, such as regulatory feature, procedure and its importance and how it operates with the mark and presence of Codes and Policies for Research Ethics, Good Clinical Practices, Data Safety Monitoring Board and Institutional Review Board. This commentary recapitulates the indispensable facts/findings for scientists/researchers who plan to carry out clinical trials.

Keywords: Clinical trials, codes and policies for research ethics, good clinical practices, data safety monitoring board, an institutional review board.

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