Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy

Huić, Mirjana; Marušić, Matko; Marušić, Ana

doi:10.1371/journal.pone.0025258

Cited by 105 publications

(101 citation statements)

References 39 publications

(42 reference statements)

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“…A P value of less than 0.05 was considered significant. 9,15 The lead and corresponding author, subject of the trial, and dates of commencement and completion of the trial were also noted. The source of funding of the trial was also extracted.…”

Section: Methodsmentioning

confidence: 99%

Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals

et al. 2014

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Section: Methodsmentioning

confidence: 99%

Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals

et al. 2014

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“…Many registry entries are incomplete, out-of-date, or have not been updated recently 13 As of October 2016, the recruitment status of nearly 21,000 ClinicalTrials.gov records is “Unknown” (i.e., listed as “Recruiting,” “Not yet recruiting,” or “Active, not recruiting,” but not confirmed within at 2 years)…”

Section: Tablementioning

confidence: 99%

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

et al. 2017

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In the decade following the journal editors’ trial registration policy, a global trial reporting system (TRS) has arisen to supplement journal publication by increasing the transparency and accountability of the clinical research enterprise (CRE), which ultimately advances evidence-based medicine. Trial registration a foundation component of the TRS. In this article, we assess impact of the trial registration on the CRE with respect to two key goals: (1) establishing a publicly accessible and structured public record of all trials and (2) ensuring access to date-stamped protocol details that change during a study. After characterizing international trial registry landscape, we summarize the published evidence of the impact of the registration laws and policies on the CRE to date. We present three analyses using ClinicalTrials.gov registration data to illustrate approaches for assessing and monitoring the TRS: (1) timing of registration (i.e., prior to trial initiation [prospective] or after trial initiation [retrospective or “late”]; (2) degree of specificity and consistency of registered primary outcome measures compared to descriptions in study protocols and published articles; and (3) a survey of the published literature to characterize how ClinicalTrials.gov data has been used in research on the CRE. These findings suggest that, while the TRS is largely moving towards goals, key stakeholders need to do more in the next decade.

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“…Huic et al looked at a different sample of 152 RCTs and found that the registry entries commonly failed to provide adequate description of key secondary outcomes (44.1% of RCTs) or primary outcomes (38.8% of RCTs). 63 Prevalence of differences between the registry entry and the journal publication varied depending on the data field of interest, ranging from 13.8% to 77.6%. However, in a more recent study, Norris et al reported a catalog of problems during their attempts to evaluate selective outcome or analysis reporting through comparison of registry entries and journal reports of trials that had been included in systematic reviews of effectiveness.…”

mentioning

confidence: 99%

Publication bias: what is it? How do we measure it? How do we avoid it?

Song¹,

Hooper²,

Loke³

2013

OAJCT

179

142

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Publication bias occurs when results of published studies are systematically different from results of unpublished studies. The term "dissemination bias" has also been recommended to describe all forms of biases in the research-dissemination process, including outcome-reporting bias, time-lag bias, gray-literature bias, full-publication bias, language bias, citation bias, and media-attention bias. We can measure publication bias by comparing the results of published and unpublished studies addressing the same question. Following up cohorts of studies from inception and comparing publication levels in studies with statistically significant or "positive" results suggested greater odds of formal publication in those with such results, compared to those without. Within reviews, funnel plots and related statistical methods can be used to indicate presence or absence of publication bias, although these can be unreliable in many circumstances. Methods of avoiding publication bias, by identifying and including unpublished outcomes and unpublished studies, are discussed and evaluated. These include searching without limiting by outcome, searching prospective trials registers, searching informal sources, including meeting abstracts and PhD theses, searching regulatory body websites, contacting authors of included studies, and contacting pharmaceutical or medical device companies for further studies. Adding unpublished studies often alters effect sizes, but may not always eliminate publication bias. The compulsory registration of all clinical trials at inception is an important move forward, but it can be difficult for reviewers to access data from unpublished studies located this way. Publication bias may be reduced by journals by publishing high-quality studies regardless of novelty or unexciting results, and by publishing protocols or full-study data sets. No single step can be relied upon to fully overcome the complex actions involved in publication bias, and a multipronged approach is required by researchers, patients, journal editors, peer reviewers, research sponsors, research ethics committees, and regulatory and legislation authorities.

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Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy

Cited by 105 publications

References 39 publications

Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals

Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

Publication bias: what is it? How do we measure it? How do we avoid it?

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