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Title: When to include clinical study reports and regulatory documents in systematic reviews
Table 1 MIF paper 20-08-18.docx  (20.77 kB)  
MIF manuscript 24-08-18_.docx  (33.24 kB)  
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Authors: Doshi, Peter
Date: 2018-10-11
Publisher: BMJ Publishing Group
Citation: Jefferson T. Doshi P. Boutron I. (2018). When to include clinical study reports and regulatory documents in systematic reviews. BMJ Evidence-Based Medicine. (Epub ahead of print) October 11. DOI: 10.1136/bmjebm-2018-110963
Abstract: Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systematic reviews. The article also describes the origins and current state of regulatory data access and summarises a survey of current systematic reviewers' practices in considering regulatory data for inclusion in systematic reviews. How to access and extract regulatory data is not addressed. Organisations and other stakeholders such as Cochrane should encourage the use of data from clinical study reports as an important source of data in reviews of pharmaceutical interventions particularly when the intervention in question is of high importance and the risk of reporting bias is great.
Subject Keywords: clinical study reports
regulatory documents
reporting bias
Systematic reviews (Medical research)
Type: Article
Appears in Collections:Dr. Peter Doshi

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