Trastuzumab: possible publication bias

Metcalfe, Scott; Burgess, Carl; Laking, George; Evans, Jackie; Wells, Susan; Crausaz, Steffan

doi:10.1016/s0140-6736(08)60706-0

Cited by 8 publications

(5 citation statements)

References 22 publications

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“…However, the updated review identified several new cases in which results of industrysponsored research were selectively reported or misrepresented in publication (Appendix 16). 136,217,219,220,222,323,324,331,332,335 Non-publication of 'negative' results was common. [317][318][319][320]322,336 For example, Psaty and Kronmal compared published and unpublished mortality findings in two trials of rofecoxib for Alzheimer's disease.…”

Section: -284mentioning

confidence: 99%

“…Because of these missing data, 'sequential trastuzumab seems more effective than it probably is'. 335 The principal investigator for the trial responded that the publication of concurrent therapy data was according to an analysis plan prespecified while data on sequential therapy were not sufficiently mature 537 Lenzer 2002 329 Delayed publication: Alteplase (a thrombolytic agent) for acute ischaemic stroke A trial found that alteplase did not improve stroke recovery and increased mortality. The negative result was not published for 6 years after the trial's completion Lenzer 2002 329 Delayed publication: Release of results from a trial on ezetimibea cholesterol-lowering drug Negative results of a trial on ezetimibe were released by the company only after a US Congressional inquiry was set up to look into why the results had not been published 2 years after the study was completed Alasbali et al 2009 332 Discrepancy between results and abstract conclusions Topical prostaglandins Alasbali et al examined the discrepancy between the statistical significance of the publication's main outcome measure and its abstract conclusions.…”

Section: Casesmentioning

confidence: 99%

See 1 more Smart Citation

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

822

682

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address. Paying by credit cardYou can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume. How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of project...

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Section: -284mentioning

confidence: 99%

Section: Casesmentioning

confidence: 99%

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

822

682

View full text Add to dashboard Cite

show abstract

“…Publication bias (PB) has the potential to distort the scientific literature [1,2]; since it is the "interest level", or statistical significance of findings, not study rigour or quality, that determines which research gets published and is subsequently available [3]. A meta-analysis of the published literature will be biased and may adversely affect decision making if PB exists.…”

Section: Introductionmentioning

confidence: 99%

Assessment of regression-based methods to adjust for publication bias through a comprehensive simulation study

Moreno

Sutton

Ades

et al. 2009

BMC Med Res Methodol

330

404

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BackgroundIn meta-analysis, the presence of funnel plot asymmetry is attributed to publication or other small-study effects, which causes larger effects to be observed in the smaller studies. This issue potentially mean inappropriate conclusions are drawn from a meta-analysis. If meta-analysis is to be used to inform decision-making, a reliable way to adjust pooled estimates for potential funnel plot asymmetry is required.MethodsA comprehensive simulation study is presented to assess the performance of different adjustment methods including the novel application of several regression-based methods (which are commonly applied to detect publication bias rather than adjust for it) and the popular Trim & Fill algorithm. Meta-analyses with binary outcomes, analysed on the log odds ratio scale, were simulated by considering scenarios with and without i) publication bias and; ii) heterogeneity. Publication bias was induced through two underlying mechanisms assuming the probability of publication depends on i) the study effect size; or ii) the p-value.ResultsThe performance of all methods tended to worsen as unexplained heterogeneity increased and the number of studies in the meta-analysis decreased. Applying the methods conditional on an initial test for the presence of funnel plot asymmetry generally provided poorer performance than the unconditional use of the adjustment method. Several of the regression based methods consistently outperformed the Trim & Fill estimators.ConclusionRegression-based adjustments for publication bias and other small study effects are easy to conduct and outperformed more established methods over a wide range of simulation scenarios.

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“…However, some reports in our sample (e.g., (23;34)), as well as further examples such as the reboxetine case (5) or the Cochrane Review on Tamiflu (35), show that routine inquiries alone are often insufficient, and despite considerable persistence and investment of resources, all relevant data may not always be provided, as in the case of Tamiflu (6;36).…”

Section: Policy Implicationsmentioning

confidence: 87%

“…Although this was not the focus of our research, several reports in our sample explicitly discussed the problem of publication bias or missing data (e.g., (22)(23)(24)(25)), and some applied strategies such as funnel plots or Egger's weighted regression statistics to investigate possible publication bias (e.g., (25;26)). While many reports put considerable effort into trying to identify unpublished data by means of different strategies, some HTA authors decided as a matter of principle not to search for unpublished data to maintain the reproducibility of the data included (e.g., (27)), or because unpublished data are difficult to search for systematically and exhaustively (e.g., (28)).…”

Section: Alternative Strategies To Identify Unpublished Datamentioning

confidence: 99%

How Health Technology Assessment Agencies Address the Issue of Unpublished Data

Kreis

Panteli²,

Busse³

2014

Int J Technol Assess Health Care

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Objectives: Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. Methods: We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Results: Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. Conclusion: International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

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Trastuzumab: possible publication bias

Cited by 8 publications

References 22 publications

Dissemination and publication of research findings: an updated review of related biases

Dissemination and publication of research findings: an updated review of related biases

Assessment of regression-based methods to adjust for publication bias through a comprehensive simulation study

How Health Technology Assessment Agencies Address the Issue of Unpublished Data

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