Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Gates, Allison; Caldwell, Patrina; Curtis, Sarah; Dans, Leonila F.; Fernandes, Ricardo M; Hartling, Lisa; Kelly, Lauren; Vandermeer, Ben; Williams, Katrina; Woolfall, Kerry; Dyson, Michele P

doi:10.1136/bmjpo-2018-000426

Cited by 6 publications

(5 citation statements)

References 27 publications

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“…We found that nearly 40% of pediatric RCTs reported having appointed a DMC, a higher estimate than in published trial reports, according to previous reviews. 6,7 We found no clear time trend on the frequency of DMCs for the period under review, although the increasing use of DMCs over time has been previously suggested. 6 Larger, multicenter, and multinational trials reported a higher frequency of DMC adoption, as did trials that employed blinding techniques, trials in younger age groups, and trials with drug or biological interventions.…”

Section: Discussioncontrasting

confidence: 50%

“…In this sample, only 17% of trial reports provided any details on DMCs, interim analysis, or early stopping. 6 Gates et al 7 reviewed a randomly selected sample of 300 pediatric trials from the Cochrane Central Register of Controlled Trials, reaching similar conclusions: the reporting on DMC was infrequent (18%), even though it was more common in trials which characteristics may suggest that DMC implementation may be warranted such as trials with drug interventions or multicentric trials.…”

Section: Introductionmentioning

confidence: 86%

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Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

et al. 2023

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Background Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics. Methods We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We used the Access to Aggregate Content of ClinicalTrials.gov database to retrieve publicly available information on trial characteristics and data on safety results. Abstracted data included reported trial design and conduct parameters, population and intervention characteristics, reasons for prematurely halting, serious adverse events, and mortality outcomes. We performed descriptive analyses on the collected data and explored the influence of clinical, methodological, and operational trial characteristics on the reported adoption of data monitoring committees. Results We identified 13,928 pediatric randomized controlled trial records, of which 39.7% reported adopting a data monitoring committee, 49.0% reported not adopting a data monitoring committee, and 11.3% did not answer on this item. While the number of registered pediatric trials has been increasing since 2008, we found no clear time trend in the reported adoption of data monitoring committees. Data monitoring committees were more common in multicenter trials (50.6% vs 36.9% for single-center), multinational trials (60.2% vs 38.7% for single-country), National Institutes of Health–funded (60.3% vs 40.1% for industry-funded or 37.5% for other funders), and placebo-controlled (47.6% vs 37.5% for other types of control groups). Data monitoring committees were also more common among trials enrolling younger participants, trials employing blinding techniques, and larger trials. Data monitoring committees were more common in trials with at least one serious adverse event (52.6% vs 38.4% for those without) as well as for trials with reported deaths (70.3% vs 38.9% for trials without reported deaths). In all, 4.9% were listed as halted prematurely, most often due to low accrual rates. Trials with a data monitoring committee were more often halted for reasons related to scientific data than trials without a data monitoring committee (15.7% vs 7.3%). Conclusion According to registry records, the use of data monitoring committees in pediatric randomized controlled trials was more frequent than previously reported in reviews of published trial reports. The use of data monitoring committees varied across key clinical and trial characteristics based on which their use is recommended. Data monitoring committees may still be underutilized in pediatric trials, and reporting of this item could be improved.

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Section: Discussioncontrasting

confidence: 50%

Section: Introductionmentioning

confidence: 86%

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

et al. 2023

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“…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 Improving the wording, content and clarity of research reports is an area of active development and a range of tools and guidelines continue to be developed.…”

Section: Reporting and Publicationmentioning

confidence: 99%

“…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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“…Responsive data monitoring may be just as effective as routine monitoring with fewer financial implications 8 , although certain vulnerable populations, (e.g. paediatrics) may benefit from external data monitoring as standard, with cost merely a secondary consideration 9 . Others argue that external data monitoring should not be done routinely.…”

Section: Introductionmentioning

confidence: 99%

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

O'Neill,

Murphy,

Reidy

et al. 2023

HRB Open Res

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Background Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ‘Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial’, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James’s Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019

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Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Cited by 6 publications

References 27 publications

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

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

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

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