Randomized clinical trials in ANCA-associated vasculitis: a systematic analysis of the WHO - International Clinical Trials Registry Platform.

Background: The analysis of the main features of randomized controlled trials (RCTs) on ANCA-associated vasculitis (AAV) can inform future study design.

Methods: We searched within the International Clinical Trials Registry Platform all registered RCTs on AAV from October 2008 to December 2018. Two reviewers selected studies according to pre-specified eligibility criteria.

Reporting quality of studies using machine learning models for medical diagnosis: a systematic review.

Aims: We conducted a systematic review assessing the reporting quality of studies validating models based on machine learning (ML) for clinical diagnosis, with a specific focus on the reporting of information concerning the participants on which the diagnostic task was evaluated on.

Method: Medline Core Clinical Journals were searched for studies published between July 2015 and July 2018. Two reviewers independently screened the retrieved articles, a third reviewer resolved any discrepancies.

External factors may influence Cochrane reviewers when classifying the risk of bias of original reports.

Objective: The objective of the study was to explore contextual factors associated with high or low risk-of-bias judgment in case of incomplete or unclear information in study reports.

Study Design And Setting: Research-on-research study, using matched case-control design, with a sample of 304 randomized controlled trials (RCTs) included in two Cochrane reviews for which there was disagreement on the risk-of-bias judgment related to incomplete or unclear information in the study report. A case was defined as an RCT judged at high or low risk of bias; a control was the same RCT judged at unclear risk.

Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design.

Objectives: Assess the frequency and reasons for disagreements in risk of bias assessments for randomised controlled trials (RCTs) included in more than one Cochrane review.

Design: Research on research study, using cross-sectional design.

Data Sources: 2796 Cochrane reviews published between March 2011 and September 2014.

The statistical significance of meta-analyses is frequently fragile: definition of a fragility index for meta-analyses.

Objectives: Meta-analyses inform clinical practice by summarizing treatment effect estimates based on results from several trials. However, the statistical significance of a meta-analysis (i.e.

Automatic screening using word embeddings achieved high sensitivity and workload reduction for updating living network meta-analyses.

Objectives: We aimed to develop and evaluate an algorithm for automatically screening citations when updating living network meta-analysis (NMA).

Study Design And Setting: Our algorithm learns from the initial screening of citations conducted when creating an NMA to automatically identify eligible citations (i.e.

Ten Years of Interventional Research in Systemic Sclerosis: A Systematic Mapping of Trial Registries.

Objective: To provide a comprehensive overview of interventional clinical trials registered in international databases and planned and conducted within the last 10 years in patients with systemic sclerosis (SSc).

Methods: We searched the International Clinical Trials Registry Platform for all records on interventional clinical trials targeting patients with SSc performed since September 2007. Two reviewers selected studies according to the prespecified eligibility criteria.

Association Between Publication Characteristics and Treatment Effect Estimates: A Meta-epidemiologic Study.

Background: Evidence about the effect on meta-analysis results of including unpublished trials or those published in languages other than English is unclear or discordant.

Purpose: To compare treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages using a meta-epidemiologic approach.

Data Sources: Cochrane reviews published between March 2011 and January 2017 and trial references cited in the reviews.

Avoidable waste of research related to outcome planning and reporting in clinical trials.

Background: Inadequate planning, selective reporting, and incomplete reporting of outcomes in randomized controlled trials (RCTs) contribute to the problem of waste of research. We aimed to describe such a waste and to examine to what extent this waste could be avoided.

Methods: This research-on-research study was based on RCTs included in Cochrane reviews with a summary of findings (SoF) table.

A mapping of 115,000 randomized trials revealed a mismatch between research effort and health needs in non-high-income regions.

Background: Concerns exist as to whether the allocation of resources in clinical research is aligned with public health needs. We evaluated the alignment between the effort of clinical research through the conduct of randomized controlled trials (RCTs) and health needs measured as the burden of diseases for all regions and a broad range of diseases.

Methods: We grouped countries into seven regions and diseases into 27 groups.

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

Objectives: To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.

Design And Setting: Cross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010.

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.

Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.

 To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades. Mapping of trials included in Cochrane reviews. Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data.

Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.

Background: Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.

Automatic classification of registered clinical trials towards the Global Burden of Diseases taxonomy of diseases and injuries.

Background: Clinical trial registries may allow for producing a global mapping of health research. However, health conditions are not described with standardized taxonomies in registries. Previous work analyzed clinical trial registries to improve the retrieval of relevant clinical trials for patients.

Association between trial registration and treatment effect estimates: a meta-epidemiological study.

Background: To increase transparency in research, the International Committee of Medical Journal Editors required, in 2005, prospective registration of clinical trials as a condition to publication. However, many trials remain unregistered or retrospectively registered. We aimed to assess the association between trial prospective registration and treatment effect estimates.

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Background: Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time.