Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK

Khin, Ni A.; Grandinetti, Cheryl; Dixey, Hayley; Yu, Bei; Skeete, Rachel; Ayalew, Kassa; Budwal-Jagait, Mandy; Cho, Seongeun‐Julia; Dasgupta, Arindam; Fisher, Andrew; Kleppinger, Cynthia; Kronstein, Phillip D.; Martin, Jennifer; McGuinness, Michael; Mulinde, Jean; Vinter, Stephen; Wakelin-Smith, Jason; Walker, Paula; Francis, Gail

doi:10.1002/cpt.2386

Cited by 7 publications

(9 citation statements)

References 5 publications

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“…The pandemic has also lowered the barriers among institutions and government agencies for pooling EHR data and making it broadly available. Curation of such data requires data harmonization and quality assessment solutions that work across multiple EHR vendors to lower the burden of manual data extraction, thereby making the process viable long-term ( 18 ). For instance, mechanical ventilation produces a wide range of measurements, settings, and event data (e.g., obstructions) often in a live stream integrated into the EHR.…”

Section: Pioneering In Critical Carementioning

confidence: 99%

A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools

Heavner

Anderson

Kashyap

et al. 2023

Critical Care Explorations

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COVID-19 highlighted the need for use of real-world data (RWD) in critical care as a near real-time resource for clinical, research, and policy efforts. Analysis of RWD is gaining momentum and can generate important evidence for policy makers and regulators. Extracting high quality RWD from electronic health records (EHRs) requires sophisticated infrastructure and dedicated resources. We sought to customize freely available public tools, supporting all phases of data harmonization, from data quality assessments to de-identification procedures, and generation of robust, data science ready RWD from EHRs. These data are made available to clinicians and researchers through CURE ID, a free platform which facilitates access to case reports of challenging clinical cases and repurposed treatments hosted by the National Center for Advancing Translational Sciences/National Institutes of Health in partnership with the Food and Drug Administration. This commentary describes the partnership, rationale, process, use case, impact in critical care, and future directions for this collaborative effort.

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Section: Pioneering In Critical Carementioning

confidence: 99%

A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools

Heavner

Anderson

Kashyap

et al. 2023

Critical Care Explorations

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“…The Medical Healthcare and products Regulatory Authority audits clinical trial conduct whilst the Care Quality Commission re-focus on auditing information and fewer on-site inspections (Khin et al, 2021;Care Quality Commission, 2022). The Data Alliance Partnership Board enable data collections whilst a Records Management Code of Practice audits contracted organizations, adult social care, and public health on standard data migration (NHS, 2021d; NHS Digital, 2022d).…”

Section: Step Secure Interoperable Flowmentioning

confidence: 99%

Culture intelligent workflow, structure, and steps

Henry

2023

Front. Artif. Intell.

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IntroductionTechnologies abstract intelligence and provide predictor and precision insight in workflows that manage disorders, similar to cardiology and hematological disease. Positive perceptions of Artificial Intelligence (AI) that support Machine Learning (ML) and Deep Learning (DL) manage transformations with a safe system that improves wellbeing. In sections, workflow introduces an eXamination (X = AI) as an end-to-end structure to culture workstreams in a step-by-step design to manage populace health in a governed system.MethodTo better healthcare outcomes, communities and personnel benefit from an explanation and an interpretive that elucidates workflow for citizens or practitioners to comprehend personalized platforms. Therefore, the author undertook structure and practice reviews and appraised perspectives that impact the management of AI in public health and medicine.ResultsFigures for the management of AI workflow illustrate and inform on the model, structure, culture, assurance, process steps, values, and governance required for abstract insights in public health and medicine. The papers' end-to-end structure with explanans in a work culture interprets the step-by-step designs that manage the success of AI. Personalized care graphics offer an explanandum in the management of biological analytic value.DiscussionHealthcare leadership collaboratives plan population health with an upstream, workplace and workstream format. Secure workflow and safety wellbeing system requirements prove that genomics and AI improve medicine. Therefore, the paper discusses group understanding of current practice, ethics, policy, and legality.Conclusion“Culture, intelligent workflow, structure, and steps” improve wellbeing with personalized care and align a percept for national opportunities, regional control, and local needs. Personalized practice cultures support analytic systems to describe, predict, precision, and prescript medicine in population health management eXaminations.

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“…10,13 Despite the higher accessibility that DCTs can provide, data quality and integrity are subject to increased risk. 16,17 Regulatory agencies particularly emphasized DCT as a novel trial design that requires robust measures to ensure data integrity. 17 Data integrity risks can either exist in study procedures (e.g., unchecked drug compliance) or in trial monitoring (e.g., unverified source data verification), all of which require the corresponding mitigation plans.…”

Section: Introductionmentioning

confidence: 99%

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

Huh,

Chung,

Park

et al. 2023

Clinical Translational Sci

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Decentralized clinical trials (DCTs) leverage digital technologies to reduce dependency on study sites and intermediaries. DCT should be balanced with accessibility and data reliability while meeting regulatory requirements. Here, we conducted a pilot study for functional constipation symptoms to investigate the feasibility of DCT. The study was an open, fully remote, randomized clinical trial in participants who had functional constipation symptoms. Electronic consent was obtained remotely, and study volunteers were screened through web‐based questionnaires. Subjects were randomized to either receive Lactobacillus and vitamin C supplements or vitamin C alone in a 1:1 ratio, which were delivered directly to subjects. Subjects kept track of bowel diaries daily during the 1‐week baseline and 2‐week treatment period using mobile applications. Bowel symptoms and the validity of the records were descriptively evaluated. A total of 30 subjects were randomized and completed the study. A total of 26.7% of subjects resided outside of the metropolitan area. Two‐week Lactobacillus treatments increased the number of defecations (+0.80 vs. +0.46 times per week) and decreased the defecation time (‐3.94 h vs. ‐1.62 h) compared to the comparator group. Overall, 67.1% of bowel diary records were completed in accordance with the schedule while 32.9% were not. Implementation of DCTs can facilitate geographic accessibility but should be guaranteed for data reliability. Prompt detection of errors and response using objective metrics would be required.

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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK

Cited by 7 publications

References 5 publications

A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools

A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools

Culture intelligent workflow, structure, and steps

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

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