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临床药理学中的良好发表规范:透明度、循证医学与7-D评估

Good publication practices in clinical pharmacology: transparency, evidence-based medicine and the 7-D assessment.

作者信息

Woodcock Barry G, Luger Veronika

出版信息

Int J Clin Pharmacol Ther. 2015 Oct;53(10):799-802. doi: 10.5414/CP202421.

DOI:10.5414/CP202421
PMID:26329349
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4895874/
Abstract

Transparency and evidence-based medicine are cornerstones of good publication practices (GPP), and concern publishers, editors, research investigator, and reviewers alike. Methods for implementing these principles within the framework of GPP are described. The main aspects include obtaining a Manuscript Agreement Contract, a Statement on Transparency of Authorship and a Declaration of Conflicts of Interest from the authors. Assessing whether a manuscript meets the requirements of EBM is demonstrated using the "7-D assessment". The main purpose of this tool is to established that the (1) right Design, (2) right Diagnosis, (3) right Drug molecule, (4) right Dosage, (5) right Data, (6) right Deductions, and (7) right Documentation have been implemented in order to meet the objectives of the investigation. If the findings from any one of these assessments is questionable, the compliance of the research with EBM principles will be weakened and the reviewers and editors will make recommendations to the publisher accordingly. The guidelines described will help to provide a fair and transparent process of scientific publication and foster the freedom of clinical pharmacological research.

摘要

透明度和循证医学是良好出版规范(GPP)的基石,涉及出版商、编辑、研究人员和同行评审人员等各方。本文描述了在GPP框架内实施这些原则的方法。主要方面包括从作者处获取《稿件协议合同》、《作者身份透明度声明》和《利益冲突声明》。使用“7-D评估”来证明稿件是否符合循证医学的要求。该工具的主要目的是确定为实现研究目标已实施了(1)正确的设计、(2)正确的诊断、(3)正确的药物分子、(4)正确的剂量、(5)正确的数据、(6)正确的推论和(7)正确的记录。如果这些评估中的任何一项结果存在疑问,研究对循证医学原则的遵循程度将被削弱,同行评审人员和编辑将相应地向出版商提出建议。所描述的指南将有助于提供一个公平、透明的科学出版过程,并促进临床药理学研究的自由。

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本文引用的文献

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Research Methods & Reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines.研究方法与报告。传达公司资助医学研究的良好出版规范:GPP2指南。
BMJ. 2009 Nov 27;339:b4330. doi: 10.1136/bmj.b4330.
2
Good publication practice guidelines for medical communications agencies: a MedComm perspective.医学传播机构良好出版规范指南:医学传播视角
Curr Med Res Opin. 2009 Feb;25(2):453-61. doi: 10.1185/03007990802646584.
3
Evidence based medicine: what it is and what it isn't.循证医学:它是什么以及不是什么。
BMJ. 1996 Jan 13;312(7023):71-2. doi: 10.1136/bmj.312.7023.71.