一个用于行业数据传播与独立分析的模型。 - Suppr

A model for dissemination and independent analysis of industry data.

作者信息

Krumholz Harlan M, Ross Joseph S

机构信息

Section of Cardiovascular Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.

出版信息

JAMA. 2011 Oct 12;306(14):1593-4. doi: 10.1001/jama.2011.1459.

DOI:10.1001/jama.2011.1459

PMID:21990302

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3688082/

Abstract

摘要

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4977/3688082/aa93f562cbec/nihms459258f1.jpg

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A model for dissemination and independent analysis of industry data.一个用于行业数据传播与独立分析的模型。

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European drug agency under fire: critics charge that trial data are too inaccessible.欧洲药品管理局遭抨击：批评者指责试验数据难以获取。

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Clinical trial data as a public good.作为公共产品的临床试验数据。

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[Beyond "data sharing"].超越“数据共享”

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Few studies reporting results at US government clinical trials site.很少有研究报告在美国政府临床试验地点的结果。

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Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.医学研究中的保密法与保密性：改善公众获取药物安全数据的途径

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Predictable materiality: a need for common criteria governing the disclosure of clinical trial results by publicly-traded pharmaceutical companies.可预测的重要性：对规范上市公司披露临床试验结果的通用标准的需求。

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Inadequacy of remote desktop interface for independent reanalysis of data from drug trials.远程桌面接口在对药物试验数据进行独立重新分析方面的不足。

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GlaxoSmithKline on its remote desktop interface for independent reanalysis of drug trial data.葛兰素史克公司关于其用于药物试验数据独立重新分析的远程桌面界面。

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Change in Off-Label Use of Bone Morphogenetic Protein in Spine Surgery and Associations with Adverse Outcome.脊柱手术中骨形态发生蛋白的非标签使用变化及其与不良结局的关联。

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How do you know it is true? Integrity in research and publications: AOA critical issues.你如何知道它是真的？研究与出版物中的诚信：美国眼科学会的关键问题。

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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。

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Persistence of cardiovascular risk after rofecoxib discontinuation.停用罗非昔布后心血管风险的持续存在。

Arch Intern Med. 2010 Dec 13;170(22):2035-6. doi: 10.1001/archinternmed.2010.461.

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.瑞波西汀治疗重性抑郁障碍的急性期疗效：基于已发表和未发表的安慰剂对照及选择性 5-羟色胺再摄取抑制剂对照试验的系统评价和荟萃分析。

BMJ. 2010 Oct 12;341:c4737. doi: 10.1136/bmj.c4737.

Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.罗非昔布安慰剂对照临床试验数据的汇总分析：上市后药品安全性监测的经验教训

Arch Intern Med. 2009 Nov 23;169(21):1976-85. doi: 10.1001/archinternmed.2009.394.

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.注册后临床试验的发布：一项横断面分析。

PLoS Med. 2009 Sep;6(9):e1000144. doi: 10.1371/journal.pmed.1000144. Epub 2009 Sep 8.

The role of litigation in defining drug risks.诉讼在界定药物风险方面的作用。

JAMA. 2007 Jan 17;297(3):308-11. doi: 10.1001/jama.297.3.308.

The strengths and limitations of meta-analyses based on aggregate data.基于汇总数据的荟萃分析的优势与局限性。

BMC Med Res Methodol. 2005 Apr 25;5:14. doi: 10.1186/1471-2288-5-14.

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A model for dissemination and independent analysis of industry data.

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