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. 2018 Dec;23(6):210-217.
doi: 10.1136/bmjebm-2018-110963. Epub 2018 Oct 11.

When to include clinical study reports and regulatory documents in systematic reviews

Tom Jefferson  1   2 , Peter Doshi  2   3 , Isabelle Boutron  4   5 , Su Golder  6   7 , Carl Heneghan  1   2 , Alex Hodkinson  8   9 , Mark Jones  2   10 , Carol Lefebvre  11   12 , Lesley A Stewart  9   13
Affiliations

When to include clinical study reports and regulatory documents in systematic reviews

Tom Jefferson et al. BMJ Evid Based Med. 2018 Dec.

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.

Keywords: public health.

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Conflict of interest statement

Competing interests: All authors except AH report funding from the Cochrane Methods Innovation Fund to undertake this project. In addition, TJ was a corecipient of a UK National Institute for Health Research grant (HTA—10/80/01 Update and amalgamation of two Cochrane reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children; https://www.journalslibrary.nihr.ac.uk/programmes/hta/108001#/). TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011–2014, TJ acted as an expert witness in a litigation case related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997–1999), GSK (2001–2002), Sanofi-Synthelabo (2003) and IMS Health (2013). In 2014–2016, TJ was a member of three advisory boards for Boehringer Ingelheim. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. TJ has a potential financial conflict of interest on the drug oseltamivir. TJ was a cosignatory of a complaint to the European Ombudsman on maladministration in relation to the EMA investigation of possible harms from HPV vaccines. PD reports reimbursement from the European Respiratory Society, grants from UK NIHR, the American Association of Colleges of Pharmacy and the Laura and John Arnold Foundation, all outside the submitted work. PD is also an associate editor of The BMJ and an unpaid member of the IMEDS steering committee at the Reagan-Udall Foundation for the FDA, which focuses on drug safety research. IB is deputy director of the French EQUATOR centre; and member of the CONSORT steering committee. CH reports he has received expenses and fees for his media work. He has received expenses from WHO and holds grant funding from the NIHR, the NIHR School of Primary Care Research, THE NIHR BRC Oxford and WHO. He has received financial remuneration from an asbestos case. He has also received income from the publication of a series of toolkit books published by Blackwells. On occasion, he receives expenses for teaching EBM and is also paid for his GP work in NHS out of hours. CEBM jointly runs the Evidence Live Conference with The BMJ and the Overdiagnosis Conference with some international partners, which are based on a non-profit making model. He is Editor-in-Chief of BMJ Evidence-Based Medicine. LAS is an employee of the University of York. She previously received a research grant from YODA for her research team to independently analyse individual participant data and data from CSRs supplied by Medtronic.

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