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Impact of FDAAA on Registration, Results Reporting, and Publication of Clinical Trials Evaluating New Neuropsychiatric Drugs Approved Between 2005 and 2014

机译：FDAAA对注册，结果报告和发表临床试验的影响，评估2005年至2014年批准的新神经精神药物

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作者
Zou, Constance Xuanyi.;
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作者单位

Yale University.;

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授予单位 Yale University.;
学科
学位 M.D.
年度 2019
页码 47 p.
总页数 47
原文格式 PDF
正文语种 eng
中图分类 AAI13814825;
关键词
Clinical trials; ClinicalTrials.gov; Neurology; New drugs; Psychiatry; Publication bias;

机译：临床试验;ClinicalTrials.gov;神经学;新药;精神病学;出版物偏见;

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专利

1. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study [J] . Constance X. Zou, Jessica E. Becker, Adam T. Phillips, Trials . 2018,第1期

机译：支持FDAAA之前和之后FDA批准神经精神药物的临床试验的注册，结果报告和出版偏倚：一项回顾性队列研究
2. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 [J] . David Korn, Jennifer E Miller, Joseph S Ross BMJ Open . 2015,第11期

机译：临床试验注册，报告，出版和符合FDAAA：2012年FDA批准的新药的横断面分析和排名
3. Evaluating the impacts of the FDA's guidance for patient-reported outcomes (PROs) measures on clinical trial-based approved drug product labeling claims, 2006-2014 [J] . Andrew C. Palsgrove Clinical research and regulatory affairs. . 2015,第1a4期

机译：评估FDA的患者报告结果（PRO）措施指南对基于临床试验的已批准药品标签声明的影响，2006-2014年
4. Assessment of the Extent of the Necessary Clinical Testing of New Biotechnological Products Based on the Analysis of Scientific Publications and Clinical Trials Reports [C] . Roman Suvorov, Ivan Smirnov, Konstantin Popov, International Conference onattern Recognition Applications and Methods . 2015

机译：基于科学出版物和临床试验报告的分析，评估新生物技术产品的必要临床试验的程度
5. THE IMPACT OF A DRUG UTILIZATION REVIEW PROGRAM AS A CHANGE AGENT ON PHYSICIAN PRESCRIBING BEHAVIOR FOLLOWING THE PUBLICATION OF A RANDOMIZED CLINICAL TRIAL. [D] . BJORNSON, DARREL CURTIS. 1987

机译：药物利用审查计划作为变更代理对随机处方临床试验发表后医生处方行为的影响。
6. Clinical trial registration reporting publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 [O] . Jennifer E Miller, David Korn, Joseph S Ross 2015

机译：临床试验注册报告出版物和FDAAA符合性：2012年FDA批准的新药的横断面分析和排名
7. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study [O] . Constance X. Zou, Jessica E. Becker, Adam T. Phillips, 2018

机译：注册，结果报告和临床试验的出版物偏见支持FDAAA之前和之后的FDA批准神经精神药物：回顾性队列研究

Impact of FDAAA on Registration, Results Reporting, and Publication of Clinical Trials Evaluating New Neuropsychiatric Drugs Approved Between 2005 and 2014

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