Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors

Taichman, Darren B.; Sahni, Peush; Pinborg, Anja; Peiperl, Larry; Lainé, Christine; James, Astrid; Hong, Sung Tae; Haileamlak, Abraham; Gollogly, Laragh; Godlee, Fiona; Frizelle, Frank; Florenzano, Fernando; Drazen, Jeffrey M.; Bauchner, Howard; Baethge, Christopher; Backus, Joyce

doi:10.1371/journal.pmed.1002315

Cited by 112 publications

(47 citation statements)

References 2 publications

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“…The Journal of the American Society of Nephrology (JASN) subscribes to the ICMJE Data Sharing policy for clinical trials 14 . All manuscripts of clinical trials must submit a data sharing plan according to ICMJE standards 15 . Data from systems-level analyses (e.g., such as genomics, metabolomics and proteomics) must be deposited in appropriate publicly accessible archiving sites.…”

Section: Discussionmentioning

confidence: 99%

An evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-sectional Review

Fladie

Adewumi

et al. 2019

Preprint

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Background:Reproducibility is critical to diagnostic accuracy and treatment implementation. Concurrent with clinical reproducibility, research reproducibility establishes whether the use of identical study materials and methodologies in replication efforts permit researchers to arrive at similar results and conclusions. In this study, we address this gap by evaluating nephrology literature for common indicators of transparent and reproducible research. Methods:We searched the National Library of Medicine catalog to identify 36 MEDLINE-indexed, English language nephrology journals. We randomly sampled 300 publications published between January 1, 2014, and December 31, 2018. In a duplicated and blinded fashion, two investigators screened and extracted data from the 300 publications. Results:Our search yielded 28,835 publications, of which we randomly sampled 300 publications. Of the 300 publications, 152 (50.67%) were publicly available whereas 143 (47.67%) were restricted through paywall and 5 (1.67%) were inaccessible. Of the remaining 295 publications, 123 were excluded because they lack empirical data necessary for reproducibility. Of the 172 publications with empirical data, 43 (25%) reported data availability statements, 4 (2.33%) analysis scripts, 4 (2.33%) links to a protocol, and 10 (5.81%) were pre-registered. Conclusion:Our study found that reproducible and transparent research practices are infrequently employed by the nephrology research community. Greater efforts should be made by both funders and journals, two entities that have the greatest ability to influence change. In doing so, an open science culture may eventually become the norm rather than the exception. Introduction:Reproducibility is critical to diagnostic accuracy and treatment implementation. In nephrology, a substantial body of literature is devoted to establishing the reproducibility of diagnostic tests or procedures. Examples include an evaluation of the reproducibility of the Banff classification for surveillance renal allograft biopsies among pathologists across transplant centers 1 , a novel analytic technique for renal blood oxygenation level-dependent MRI 2 , and a food frequency questionnaire among patients with chronic kidney disease 3 . This form of reproducibility is important clinically, as such studies establish our confidence in tests or procedures for applications to patient care.Concurrent with clinical reproducibility, research reproducibility establishes whether use of identical study materials and methodologies in replication efforts permit researchers to arrive at similar results and conclusions. In other cases, reproducibility may mean attempts to reanalyze study data to determine whether the same results can be obtained. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports the National Institutes of Health's (NIH) rigor and reproducibility initiative, which was created to foster greater reproducibility of studies funded by taxpayer dollars. The NIDDK also sponsors dkNET 4 , a porta...

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Section: Discussionmentioning

confidence: 99%

An evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-sectional Review

Fladie

Adewumi

et al. 2019

Preprint

View full text Add to dashboard Cite

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“…As a result, research funders, journal editors, governments, and regulators are increasingly demanding that data generators, be they academics, healthcare professionals, or industry, commit to meaningful data sharing practices (e.g., EMA Policy 0070 (EMA/240810/2013)). 31 Despite the recognized benefits of data sharing, multiple barriers are preventing its natural progression, some of which are common across datasets. 32 First, it is becoming progressively more challenging to share increasingly complex data from multiple sources in sufficient depth and detail so as to retain its scientific utility and meet data protection obligations on a global scale.…”

Section: Data Sharing and Accessmentioning

confidence: 99%

Big Data – How to Realize the Promise

Cave

Brun

Sweeney

et al. 2020

Clin Pharma and Therapeutics

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The increasing volume and complexity of data now being captured across multiple settings and devices offers the opportunity to deliver a better characterization of diseases, treatments, and the performance of medicinal products in individual healthcare systems. Such data sources, commonly labeled as big data, are generally large, accumulating rapidly, and incorporate multiple data types and forms. Determining the acceptability of these data to support regulatory decisions demands an understanding of data provenance and quality in addition to confirming the validity of new approaches and methods for processing and analyzing these data. The Heads of Agencies and the European Medicines Agency Joint Big Data Taskforce was established to consider these issues from the regulatory perspective. This review reflects the thinking from its first phase and describes the big data landscape from a regulatory perspective and the challenges to be addressed in order that regulators can know when and how to have confidence in the evidence generated from big datasets.

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“…De-identified data will be made publicly available 12 months after 1-year follow-up of the last randomized patient according to the recent ICMJE recommendations. 25…”

Section: Data Sharingmentioning

confidence: 99%

Efficacy and safety of iloprost in patients with septic shock‐induced endotheliopathy—Protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated trial

Bestle

Clausen

Søe‐Jensen

et al. 2020

Acta Anaesthesiol Scand

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Background In Europe 700.000 new cases of sepsis occur annually and more than 100.000 of these patients die due to multiorgan failure (MOF). We have identified shock‐induced endotheliopathy (SHINE) to be associated with development of MOF and mortality. Furthermore, in patients with septic shock those with circulating levels of thrombomodulin (TM) above 10 ng/mL have twice the mortality (56% vs 28%) than those with levels below this level. Pilot studies indicate that infusion of iloprost (1 ng/kg/min) is associated with improved endothelial function in patients with septic shock. Material and Methods This is a multicenter, randomized, blinded, investigator‐initiated, adaptive phase 2B trial in up to 384 patients with septic shock‐induced endotheliopathy defined by TM > 10 ng/mL who are allocated 1:1 to 72 hours continuous infusion of iloprost 1 ng/kg/min or placebo (equal volume of saline). The primary outcome is the mean daily modified Sequential Organ Failure Assessment (SOFA) score in the ICU up to day 90. Secondary outcomes include 28‐ and 90‐day all‐cause mortality, days alive without vasopressor in the ICU within 90 days, days alive without mechanical ventilation in the ICU within 90 days, days alive without renal replacement therapy in the ICU within 90 days, numbers of serious adverse reactions, and the number of serious adverse events within the first 7 days. Discussion This trial tests the safety and efficacy of iloprost vs placebo for 72 hours in patients with septic shock and SHINE. The outcome measures focus on the potential effect of the intervention to mitigate organ failure. Trial registration COMBAT‐SHINE trial—EudraCT no. 2019‐001131‐31—Clinicaltrials.gov: NCT04123444—Ethics Committee no. H‐19018258.

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Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors

Abstract: The International Committee of Medical Journal Editors announces requirements that a data sharing plan be prospectively registered, and a data sharing statement be included in submitted manuscripts, for clinical trials to be published in ICMJE journals.

Cited by 112 publications

References 2 publications

An evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-sectional Review

An evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-sectional Review

Big Data – How to Realize the Promise

Efficacy and safety of iloprost in patients with septic shock‐induced endotheliopathy—Protocol for the multicenter randomized, placebo‐controlled, blinded, investigator‐initiated trial

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