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循证研究中的多中心临床试验——关于印度情况的叙述性综述

Multi-centric clinic trials in evidence-based research - A narrative review on the Indian scenario.

作者信息

Patil Deepa J, Vyas Tarun, Kataria Ajay P S, Rajput Rajan, Ashem Albert, Kumar Mukesh

机构信息

Department of Oral Medicine and Radiology, K. M. Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Vadodara, Gujarat, India.

Department of Oral Medicine and Radiology, Vyas Dental College and Hospital, Jodhpur, Rajasthan, India.

出版信息

J Family Med Prim Care. 2023 May;12(5):863-867. doi: 10.4103/jfmpc.jfmpc_2257_22. Epub 2023 May 31.

DOI:10.4103/jfmpc.jfmpc_2257_22
PMID:37448913
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10336936/
Abstract

Evidence-based health care is gaining prominence since the past many decades. The ultimate goal of evidence-based medicine is providing the best available treatment to patients. The boom in pharmacy sector has seen a rapid rise in randomised controlled clinical trials. Novel medicines or diagnostic tests must be tested before introducing to the target population. Randomised controlled trials are at the top hierarchy of evidence-based health care, especially for testing newly invented drugs. The results obtained from randomised controlled trials cannot be generalised to the entire population. This has led to the evolvement of multi-centre trials in evidence-based research. Multi-centre trials can overcome the barriers associated with single-centre clinical trials. The conduct of multi-centre trials is still in a budding stage in India. Although there are many ongoing multi-centre trials in India, very few trials are conducted among the dental fraternity. The conduct of such trials has its own set of challenges involving funding, ethical committee approval, and logistic requirements. This paper will discuss the growth of multi-centre research, steps involved in conduct of multi-centre trials, and the challenges faced in conducting these trials by the dental specialists in India.

摘要

在过去几十年里,循证医疗越来越受到重视。循证医学的最终目标是为患者提供最佳的可用治疗。随着制药行业的蓬勃发展,随机对照临床试验迅速增加。新型药物或诊断测试在引入目标人群之前必须进行测试。随机对照试验处于循证医疗的最高层级,尤其是用于测试新发明的药物。从随机对照试验中获得的结果不能推广到整个人口。这导致了循证研究中多中心试验的发展。多中心试验可以克服与单中心临床试验相关的障碍。多中心试验在印度仍处于萌芽阶段。尽管印度有许多正在进行的多中心试验,但在牙科界进行的试验却很少。进行此类试验有其自身一系列的挑战,涉及资金、伦理委员会批准和后勤需求。本文将讨论多中心研究的发展、进行多中心试验所涉及的步骤,以及印度牙科专家在进行这些试验时所面临的挑战。

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