Clinical trial designs of new medicinal products for treating schizophrenia: Discussion of EMA's Guideline and a Better Long Term Trial Design

Jiang Haibiao; Zhang Jingjing

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Clinical trial designs of new medicinal products for treating schizophrenia: Discussion of EMA's Guideline and a Better Long Term Trial Design

机译：用于治疗精神分裂症的新药物的临床试验设计：讨论EMA指南和更好的长期试验设计

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Background and Objectives: Schizophrenia is a severe chronic disease. Endpoint variables lack objectivity and the diagnostic criteria have evolved with time. In order to guide the development of new drugs, European Medicines Agency (EMA) issued a guideline on the clinical investigation of medicinal products for the treatment of schizophrenia.

机译：背景与目的：精神分裂症是一种严重的慢性疾病。端点变量缺乏客观性，诊断标准随时间而发展。为了指导新药的开发，欧洲药品管理局（EMA）发布了用于治疗精神分裂症的药物临床研究指南。

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《The European journal of psychiatry》 |2016年第1期|共12页
作者
Jiang Haibiao; Zhang Jingjing;
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正文语种 eng
中图分类神经病学与精神病学;
关键词
Schizophrenia; New drug; Clinical trial design;

机译：精神分裂症;新药;临床试验设计;

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1. Clinical trial designs of new medicinal products for treating schizophrenia: Discussion of EMA's Guideline and a Better Long Term Trial Design [J] . Jiang Haibiao, Zhang Jingjing The European journal of psychiatry . 2016,第1期

机译：用于治疗精神分裂症的新药物的临床试验设计：讨论EMA指南和更好的长期试验设计
2. Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design [J] . The European journal of psychiatry. . 2016,第1期

机译：治疗精神分裂症的新药物的临床试验设计：EMA指南的讨论和更好的长期试验设计
3. Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design [J] . Jiang Haibiao, Jiangsu Hansoh Pharmaceutical China, Mental Health Center of Minhang District Shanghai China, The European Journal of Psychiatry (Spanish Edition) . 2016,第1期

机译：治疗精神分裂症的新药物的临床试验设计：EMA指南的讨论和更好的长期试验设计
4. Software Agents in Clinical Workflow, Clinical Guidelines and Clinical Trial Medicine [C] . Alexis Andrew Miller, Fiona Hegi-Johnson Principles and practice of multi-agent systems. . 2010

机译：临床工作流程，临床指南和临床试验医学中的软件代理
5. Effects of trial design on participation and costs in clinical trials, with an examination of cost analysis methods and data sources. [D] . Kilgore, Meredith L. 2004

机译：试验设计对临床试验参与和费用的影响，并检查费用分析方法和数据源。
6. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products [O] . Joop van Gerven, Milton Bonelli 2018

机译：关于EMA指南的评论该指南旨在确定和减轻使用研究性药物进行的首次人类和早期临床试验的风险
7. P465 UC trial designed more than 5 years ago in the light of the EMA guideline on the development of new medicinal products for the treatment of ulcerative colitis [O] . R Laoun, R Hofmann 2019

机译：P465 UC审判设计了超过5年前的鉴于EMA关于开发新药产品的溃疡性结肠炎的指导方针

Clinical trial designs of new medicinal products for treating schizophrenia: Discussion of EMA's Guideline and a Better Long Term Trial Design

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