Why New Drugs, Treatments, and Medical Devices Still Needs to be Tested Clinically Before Making it Available in the Market? A Systematic Review

Naiya Patel
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引用次数: 2

Abstract

Objective Testing a new drug, treatment, and medical device clinically is critically important before prescribing it to patient. Not determining the drug’s safety and efficacy through clinical trials might impose life threatening outcomes on its consumers. The research paper describes the critical factors associated for testing any new drugs clinically, as limited research is performed in this field of public health. Study Design A qualitative systematic literature review was performed by mining relevant original peer reviewed research papers as well as some online resources like MedlinePlus due to limited availability of studies on such critical topic. Methods The databases used were Web of Sciences core collection, PubMed, Google scholar. The keywords used to search research papers were “clinical trials”, “testing new drugs”, “history of testing drugs”, “evidence-based medicine”. Conclusion Drugs which are prescribed to critical target population like pregnant women and children should be more often clinically tested if possible as majority of them are available in the market without Food and Drug Administration (FDA) approval. The abusive potential of any new drug could end up taking lives of innocent individuals. More evidence-based medicine can help translate research results on a heterogeneous population efficiently.
为什么新药、治疗方法和医疗设备在上市前仍需进行临床测试?系统综述
目的在给患者开处方之前,对一种新药、治疗方法和医疗器械进行临床测试是至关重要的。如果不通过临床试验来确定药物的安全性和有效性,可能会给消费者带来危及生命的后果。该研究论文描述了与临床测试任何新药相关的关键因素,因为在这一公共卫生领域进行的研究有限。研究设计由于这一关键课题的研究有限,我们通过挖掘相关的同行评审的原始研究论文以及MedlinePlus等在线资源进行了定性的系统文献综述。方法采用Web of Sciences核心合集、PubMed、谷歌scholar等数据库。搜索研究论文的关键词是“临床试验”、“新药试验”、“药物试验史”、“循证医学”。结论针对孕妇和儿童等关键目标人群的药物,大部分未经FDA批准就可以在市场上销售,应尽可能多地进行临床试验。任何一种新药的滥用潜力最终都可能夺走无辜的生命。更多的循证医学可以帮助有效地转化异质性人群的研究结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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