Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors

Angelis, Catherine De; Drazen, Jeffrey M.; Frizelle, Frank; Haug, Charlotte; Hoey, John; Horton, Richard; Kotzin, Sheldon; Lainé, Christine; Marušić, Ana; Overbeke, A. John P.M.; Schroeder, Torben V.; Sox, Harold C.; Weyden, Martin B Van Der

doi:10.7326/0003-4819-141-6-200409210-00109

Cited by 321 publications

(271 citation statements)

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“…At the moment, prospective registration is advocated for diagnostic accuracy studies but not a prerequisite like it is for intervention studies in order to be considered for publication in journals associated with the International Committee of Medical Journal Editors (ICMJE) [78]. Empirical studies to assess and understand the mechanisms that may induce publication bias in DTA studies, however, are needed.…”

Section: Discussionmentioning

confidence: 99%

Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

Enst

Ochodo

Scholten

et al. 2014

BMC Med Res Methodol

296

196

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BackgroundThe validity of a meta-analysis can be understood better in light of the possible impact of publication bias. The majority of the methods to investigate publication bias in terms of small study-effects are developed for meta-analyses of intervention studies, leaving authors of diagnostic test accuracy (DTA) systematic reviews with limited guidance. The aim of this study was to evaluate if and how publication bias was assessed in meta-analyses of DTA, and to compare the results of various statistical methods used to assess publication bias.MethodsA systematic search was initiated to identify DTA reviews with a meta-analysis published between September 2011 and January 2012. We extracted all information about publication bias from the reviews and the two-by-two tables. Existing statistical methods for the detection of publication bias were applied on data from the included studies.ResultsOut of 1,335 references, 114 reviews could be included. Publication bias was explicitly mentioned in 75 reviews (65.8%) and 47 of these had performed statistical methods to investigate publication bias in terms of small study-effects: 6 by drawing funnel plots, 16 by statistical testing and 25 by applying both methods. The applied tests were Egger’s test (n = 18), Deeks’ test (n = 12), Begg’s test (n = 5), both the Egger and Begg tests (n = 4), and other tests (n = 2). Our own comparison of the results of Begg’s, Egger’s and Deeks’ test for 92 meta-analyses indicated that up to 34% of the results did not correspond with one another.ConclusionsThe majority of DTA review authors mention or investigate publication bias. They mainly use suboptimal methods like the Begg and Egger tests that are not developed for DTA meta-analyses. Our comparison of the Begg, Egger and Deeks tests indicated that these tests do give different results and thus are not interchangeable. Deeks’ test is recommended for DTA meta-analyses and should be preferred.

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Section: Discussionmentioning

confidence: 99%

Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

Enst

Ochodo

Scholten

et al. 2014

BMC Med Res Methodol

296

196

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“…The importance of this principle is such that many granting agencies and journals now require trial pre-registration. 32,33 Various clinical registries are available for this purpose, including ISRCTN.org and ClinicalTrials.gov. Publication of protocols in the scientific literature, where they are available for widespread peer review, has also been advocated.…”

Section: Ethical Research Conduct and Ethics Review Boardsmentioning

confidence: 99%

Design and execution of clinical trials in orthopaedic surgery

Mundi

Chaudhry

Mundi

et al. 2014

Bone & Joint Research

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High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.Cite this article: Bone Joint Res 2014;3:161–8.

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“…2 However, critics worry that involvement of the pharmaceutical industry may bias the design and interpretation of RCTs. [2][3][4][5] In a 2002 survey of 3247 National Institutes of Health scientists, 15.5% admitted to changing the design, methods, or results of a study in response to pressure from a funding source. 6 A systematic review of the role of funding on study outcome showed that industry funded studies were more likely than non-industry funded studies to have positive efficacy results (risk ratio 1.24, 95% confidence interval 1.14 to 1.…”

Section: Introductionmentioning

confidence: 99%

“…14 The ICMJE recommends that all trials should be pre-registered in databases such as clinicaltrials.gov to minimize publication bias and increase transparency around trial conduct. 15 However, not all journals enforce the recommendations. 16 Even when trials are…”

Section: Introductionmentioning

confidence: 99%

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Ahn

Woodbridge

Abraham

et al. 2017

BMJ

133

109

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Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding.Design Cross sectional study of randomized controlled trials (RCTs).Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.Participants Random sample of RCTs focused on drug efficacy.Main outcome measure Association between financial ties of principal investigators and study outcome.Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

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Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors

Cited by 321 publications

References 0 publications

Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

Design and execution of clinical trials in orthopaedic surgery

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

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