Completeness of protocols for clinical trials in children submitted to ethics committees

Joseph, Pathma D.; Barnes, Elizabeth H; Hynes, Kay; Choong, Catherine S.; Turner, Sean; Vosk, Claire; White, Jessie; Richichi, Kate; Craig, Jonathan C.

doi:10.1111/jpc.14189

Cited by 6 publications

(8 citation statements)

References 34 publications

(79 reference statements)

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“…The sample of the original study within each of the included meta-research studies varied. One meta-research study surveyed congress delegates [ 29 ], one study examined first-submission protocols for randomized controlled trials submitted to four hospital ethics committees [ 17 ], and 14 studies examined randomized or quasi-randomized primary studies published during a specific time period in a range of journals [ 10 , 11 , 18 , 21 – 28 , 31 , 32 , 34 ] or in specific databases [ 16 , 19 , 20 , 30 ]. Finally, one study examined the use of previously published systematic reviews when publishing a new systematic review [ 33 ].…”

Section: Resultsmentioning

confidence: 99%

Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

Andreasen

Nørgaard²,

Draborg³

et al. 2022

PLoS ONE

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Background Redundancy is an unethical, unscientific, and costly challenge in clinical health research. There is a high risk of redundancy when existing evidence is not used to justify the research question when a new study is initiated. Therefore, the aim of this study was to synthesize meta-research studies evaluating if and how authors of clinical health research studies use systematic reviews when initiating a new study. Methods Seven electronic bibliographic databases were searched (final search June 2021). Meta-research studies assessing the use of systematic reviews when justifying new clinical health studies were included. Screening and data extraction were performed by two reviewers independently. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. Results were synthesized narratively and quantitatively using a random-effects meta-analysis. The protocol has been registered in Open Science Framework (https://osf.io/nw7ch/). Results Twenty-one meta-research studies were included, representing 3,621 original studies or protocols. Nineteen of the 21 studies were included in the meta-analysis. The included studies represented different disciplines and exhibited wide variability both in how the use of previous systematic reviews was assessed, and in how this was reported. The use of systematic reviews to justify new studies varied from 16% to 87%. The mean percentage of original studies using systematic reviews to justify their study was 42% (95% CI: 36% to 48%). Conclusion Justification of new studies in clinical health research using systematic reviews is highly variable, and fewer than half of new clinical studies in health science were justified using a systematic review. Research redundancy is a challenge for clinical health researchers, as well as for funders, ethics committees, and journals.

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Section: Resultsmentioning

confidence: 99%

Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

Andreasen

Nørgaard²,

Draborg³

et al. 2022

PLoS ONE

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“…A confused ethical analysis continues to frustrate efforts to reduce this threat. [44][45][46] We have attempted to show why the responsibilities of RECs extend beyond judging individual research proposals. The British ethicist Richard Ashcroft has made the welcome suggestion that RECs might take into account and use their influence to promote and protect the interests of non-participants in research and future patients.…”

Section: Improving the Relevance And Efficiency Of Research Ethics Reviewmentioning

confidence: 99%

Protecting the public from the adverse effects of confused research ethics

Chalmers

Glasziou

2021

J R Soc Med

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“…The CONSORT statement and other reporting guidelines, promoted by groups such as the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network, have sought to improve the completeness of trial reporting. However, deficiencies in reporting are still found in areas such as study protocols, 37 consent and recruitment, 38 description of the primary outcome 39 and reports to data monitoring committees 40 . Reporting guidelines are used inappropriately and authors have even been found to ‘spin’ the wording of articles to distort the interpretation of results 41,42 .…”

Section: Reporting and Publicationmentioning

confidence: 99%

Fake news and fake research: Why meta‐research matters more than ever

McGee

Dawson

2020

J Paediatrics Child Health

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Research is in a crisis of credibility, and this is to the peril of all paediatricians. Billions of dollars are being wasted each year because research is not planned, badly conducted or poorly reported, and this is on a background of rapidly reducing research budgets. How can paediatricians, families and patients make informed treatment choices if the evidence base is absent or not trustworthy? This article discusses why meta-research now matters more than ever, how it can help solve this crisis of credibility and how this should lead to more efficient and effective clinical care. The field of meta-research or research-on-research is the ultimate big picture approach to identifying and solving issues of bias, error, misconduct and waste in research. Meta-researchers value authenticity over aesthetics and quality over quantity. The utility of meta-research does not rely on accusations or critical assessments of individual research, but through highlighting where and how the scientific method and research standards across all fields can be improved. Meta-researchers study, analyse and critique the research pathway, focusing on elements such as methods (how to conduct), evaluation (how to test), reporting (how to communicate), reproducibility (how to verify) and incentives (how to reward). In the current climate it is now more critical than ever that we make use of meta-research and prioritise high-quality high-impact research, ultimately leading to improved patient outcomes.

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Completeness of protocols for clinical trials in children submitted to ethics committees

Cited by 6 publications

References 34 publications

Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

Protecting the public from the adverse effects of confused research ethics

Fake news and fake research: Why meta‐research matters more than ever

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