When to include clinical study reports and regulatory documents in systematic reviews

Jefferson, Tom; Doshi, Peter; Boutron, Isabelle; Golder, Su; Heneghan, Carl; Hodkinson, Alexander; Jones, Mark; Lefebvre, Carol A.; Stewart, Lesley

doi:10.1136/bmjebm-2018-110963

Cited by 23 publications

(18 citation statements)

References 35 publications

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“…These contain more complete clinical trial information, 43 and their inclusion in systematic reviews has been shown to reduce reporting biases, 44 particularly of harms outcomes. 45 Following calls for the release 46,47 and greater use of regulatory documents in systematic reviews, 48 this is the first case of industry volunteering these data for meta-analysis, as far as we are aware.…”

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confidence: 96%

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials

Goossen

Becker

Marshall

et al. 2020

American Journal of Kidney Diseases

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The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. Study Design: Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. Setting & Study Populations: Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. Selection Criteria for Studies: Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. Data Extraction: 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. Analytic Approach: Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. Results: 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24 h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, −40.84 [95% CI, −48.09 to −33.59] g/ long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (−0.50 [95% CI, −1.19 to 0.18] mmol/L; low certainty) and hemoglobin A 1c levels (−0.14% [95% CI, −0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. Limitations: Trial quality was variable. The followup period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. Conclusions: Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and costeffectiveness associated with icodextrin is needed. T he prevalence of kidney replacement therapy is expected to increase steeply. 1 Approximately 15% of dialysis patients globally use peritoneal dialysis (PD), and this proportion is increasing. 2 PD is probably associated with the same survival as hemodialysis (HD) 3-6 but pre...

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confidence: 96%

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials

Goossen

Becker

Marshall

et al. 2020

American Journal of Kidney Diseases

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“…A number of examples of journal publications using CSRs in academic research [4, 8–11, 14, 15] were cited within a conference presentation delivered by Tom Jefferson in 2017 [20] and within a related published report in 2018 [21]. This section summarises and discusses the research purposes and methodology applied within these examples, in addition to a recently published Cochrane Review involving SJN which has made use of CSR data in analysis [16].…”

Section: Resultsmentioning

confidence: 99%

“…A survey was conducted among Cochrane authors between June and September 2016 regarding any experiences and opinions they had of using CSRs and ‘other regulatory documents’ (defined as any document produced by or held by a regulatory agency) in Cochrane Reviews [20, 21, 29].…”

Section: Resultsmentioning

confidence: 99%

European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research

Ferran¹,

Nevitt

2019

BMC Med Res Methodol

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BackgroundClinical study reports (CSRs) have been increasingly utilised within academic research in recent years. European Medicines Agency (EMA) Policy 0070 ‘Phase 1,’ which came into effect in January 2015, requires the publication of regulatory documents such as CSRs from central applications in an anonymised format. EMA Policy 0070 requires sponsors to demonstrate careful consideration of data utility within anonymised CSRs published within the scope of the policy, yet the concept of data utility is not clearly defined in the associated anonymisation guidance.ObjectiveTo review the use of data from CSRs in published academic research and to hypothesise the potential data utility of CSRs anonymised under the objectives of EMA Policy 0070 for future academic research.MethodsReview of the objectives, research methodologies and findings of academic research reports using unpublished data from CSRs (prior to EMA Policy 0070). Semi-structured interviews with authors of academic research reports, including questions related to data utility of anonymised CSRs published under EMA Policy 0070.ResultsThirteen academic research reports were identified and reviewed. The research purposes ranged from assessment of reporting bias, comparison of methods and results with published data sources, detailed evaluation of harms and adverse events, re-analysis and novel analyses including systematic reviews and meta-analysis. All of the examples identified required access to the methods and results sections of CSRs (including aggregated summary tables) and research purposes relating to evaluation of adverse events also required access to participant narratives. Retaining anonymised participant narratives relating to interventions, findings and events, while maintaining an acceptably low risk of participant re-identification, may provide an important gain in data utility and further understanding of drug safety profiles.ConclusionsThis work provides an initial insight into the previous use of CSR data and current practices for including regulatory data in academic research. This work also provides early guidance to qualitatively assess and document data utility within anonymised CSRs published under EMA Policy 0070.

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“…However, the fact there was only one missed study could indicate that searches for Cochrane reviews are potentially not broad enough in terms of less mainstream databases and non-English language sources. Options for future objectives of the CSS could be to target non-English language material and other record types such as clinical study reports [12,13].…”

Section: Discussionmentioning

confidence: 99%

Cochrane Centralised Search Service showed high sensitivity identifying randomized controlled trials: A retrospective analysis

Noel-Storr

Dooley²,

Wisniewski

et al. 2020

Journal of Clinical Epidemiology

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Background and objectives: The Cochrane Central Register of Controlled Trials (CENTRAL) is compiled from a number of sources, including PubMed and Embase. Since 2017, we have increased the number of sources feeding into CENTRAL and improved the efficiency of our processes through the use of application programming interfaces, machine learning, and crowdsourcing.Our objectives were twofold: (1) Assess the effectiveness of Cochrane's centralized search and screening processes to correctly identify references to published reports which are eligible for inclusion in Cochrane systematic reviews of randomized controlled trials (RCTs). (2) Identify opportunities to improve the performance of Cochrane's centralized search and screening processes to identify references to eligible trials. Methods: We identified all references to RCTs (either published journal articles or trial registration records) with a publication or registration date between 1st January 2017 and 31st December 2018 that had been included in a Cochrane intervention review. We then viewed an audit trail for each included reference to determine if it had been identified by our centralized search process and subsequently added to CENTRAL. Results: We identified 650 references to included studies with a publication year of 2017 or 2018. Of those, 634 (97.5%) had been captured by Cochrane's Centralised Search Service. Sixteen references had been missed by the Cochrane's Centralised Search Service: six had PubMed-not-MEDLINE status, four were missed by the centralized Embase search, three had been misclassified by Cochrane Crowd, one was from a journal not indexed in MEDLINE or Embase, one had only been added to Embase in 2019, and one reference had been rejected by the automated RCT machine learning classifier. Of the sixteen missed references, eight were the main or only publication to the trial in the review in which it had been included. Conclusion: This analysis has shown that Cochrane's centralized search and screening processes are highly sensitive. It has also helped us to understand better why some references to eligible RCTs have been missed. The CSS is playing a critical role in helping to populate CENTRAL and is moving us toward making CENTRAL a comprehensive repository of RCTs.

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When to include clinical study reports and regulatory documents in systematic reviews

Cited by 23 publications

References 35 publications

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials

European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research

Cochrane Centralised Search Service showed high sensitivity identifying randomized controlled trials: A retrospective analysis

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