Making a distinction between data cleaning and central monitoring in clinical trials

Love, Sharon; Yorke-Edwards, Victoria; Díaz-Montaña, Carlos; Murray, Macey L; Masters, Lindsey; Gabriel, Michelle; Joffe, Nicola; Sydes, Matthew R.

doi:10.1177/1740774520976617

Cited by 5 publications

(3 citation statements)

References 3 publications

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“…Elsewhere, data cleaning is often confused with monitoring. 38 Lack of structured language for describing monitoring Most protocol papers in this review did not provide a dedicated, structured paragraph to describe monitoring and this might jeopardise readability. The example given below shows a reasonable succinct description of monitoring.…”

Section: Auditing Is Misleading In Describing Monitoringmentioning

confidence: 99%

Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers

et al. 2023

Self Cite

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Background: Monitoring is essential to ensure patient safety and data integrity in clinical trials as per Good Clinical Practice. The Standard Protocol Items: Recommendations for Interventional Trials Statement and its checklist guides authors to include monitoring in their protocols. We investigated how well monitoring was reported in published ‘protocol papers’ for contemporary randomised controlled trials. Methods: A systematic search was conducted in PubMed to identify eligible protocol papers published in selected journals between 1 January 2020 and 31 May 2020. Protocol papers were classified by whether they reported monitoring and, if so, by the details of monitoring. Data were summarised descriptively. Results: Of 811 protocol papers for randomised controlled trials, 386 (48%; 95% CI: 44%–51%) explicitly reported some monitoring information. Of these, 20% (77/386) reported monitoring information consistent with an on-site monitoring approach, and 39% (152/386) with central monitoring, 26% (101/386) with a mixed approach, while 14% (54/386) did not provide sufficient information to specify an approach. Only 8% (30/386) of randomised controlled trials reported complete details about all of scope, frequency and organisation of monitoring; frequency of monitoring was the least reported. However, 6% (25/386) of papers used the term ‘audit’ to describe ‘monitoring’. Discussion: Monitoring information was reported in only approximately half of the protocol papers. Suboptimal reporting of monitoring hinders the clinical community from having the full information on which to judge the validity of a trial and jeopardises the value of protocol papers and the credibility of the trial itself. Greater efforts are needed to promote the transparent reporting of monitoring to journal editors and authors.

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Section: Auditing Is Misleading In Describing Monitoringmentioning

confidence: 99%

Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers

et al. 2023

Self Cite

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“…Trial management should provide for smooth and reliable trial procedures including participant recruitment, randomisation, intervention application, data collection, and data cleaning [ 20 , 21 ]. Data cleaning and checking of recruitment and retention rates, for instance, need to be performed in a timely fashion, so that corrective measures can be taken early on and detrimental effects on the trial can be avoided [ 22 ]. Trial monitoring is most effective when performed on cleaned data, because incorrect processes may be missed due to poor data quality and monitoring efforts are wasted on individual data errors.…”

Section: Introductionmentioning

confidence: 99%

Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials

Klatte

Subramaniam

Benkert

et al. 2023

BMC Med Res Methodol

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Background Most randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. Thoroughly identifying trial-specific risks to enable focussing of monitoring and management efforts on these critical areas during trial conduct may allow for the timely initiation of corrective action and to improve the efficiency of trial conduct. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard. Methods We performed a literature review to identify risk indicators and trial monitoring approaches followed by a contextual analysis involving local, national and international stakeholders. Based on this work we developed a risk-tailored management approach with integrated monitoring for RCTs and including a visualizing trial dashboard. We piloted the approach and refined it in an iterative process based on feedback from stakeholders and performed formal user testing with investigators and staff of two clinical trials. Results The developed risk assessment comprises four domains (patient safety and rights, overall trial management, intervention management, trial data). An accompanying manual provides rationales and detailed instructions for the risk assessment. We programmed two trial dashboards tailored to one medical and one surgical RCT to manage identified trial risks based on daily exports of accumulating trial data. We made the code for a generic dashboard available on GitHub that can be adapted to individual trials. Conclusions The presented trial management approach with integrated monitoring enables user-friendly, continuous checking of critical elements of trial conduct to support trial teams in the academic setting. Further work is needed in order to show effectiveness of the dashboard in terms of safe trial conduct and successful completion of clinical trials.

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“…17 18 Data cleaning and checking of recruitment and retention rates, for instance, need to be performed in a timely fashion, so that corrective measures can be taken early on and detrimental effects on the trial can be avoided. 19 Trial monitoring is most effective when performed on cleaned data, because incorrect processes may be missed due to poor data quality and monitoring efforts are wasted on individual data errors. Therefore, trial management and monitoring ideally are integrated tasks that make use of accumulating data during trial conduct, i.e.…”

Section: Introductionmentioning

confidence: 99%

Development of a Risk-tailored Approach and Dashboard for Efficient Management and Monitoring of Investigator-Initiated Trials

Klatte

Subramaniam

Benkert

et al. 2022

Preprint

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Background Most randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. A comprehensive approach identifying and continuously checking critical trial risks (e.g. insufficient recruitment, missing data) to allow the timely initiation of corrective action is, therefore, needed. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard. Methods We performed a systematic literature review to identify risk indicators and trial monitoring approaches followed by a contextual analysis involving local, national and international stakeholders. Based on this work we developed a risk-tailored management approach with integrated monitoring for RCTs and including a visualizing trial dashboard. We piloted the approach and refined it in an iterative process based on feedback from stakeholders and performed formal user testing with investigators and staff of two clinical trials. Results The developed risk assessment comprises four domains (patient safety and rights, overall trial management, intervention management, trial data). An accompanying manual provides rationales and detailed instructions for the risk assessment. We programmed two trial dashboards tailored to one medical and one surgical RCT to manage identified trial risks based on daily exports of accumulating trial data. We made the code for a generic dashboard available on GitHub that can be adapted to individual trials. Conclusions The presented trial management approach with integrated monitoring enables user-friendly, continuous checking of critical elements of trial conduct to support trial teams in the academic setting.

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Making a distinction between data cleaning and central monitoring in clinical trials

Cited by 5 publications

References 3 publications

Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers

Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers

Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials

Development of a Risk-tailored Approach and Dashboard for Efficient Management and Monitoring of Investigator-Initiated Trials

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