Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective.

Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective.

Publication date: Jan 23, 2024

In early 2021, the Department of Health and Social Care in the UK called for research on the safety and immunogenicity of concomitant administration of COVID-19 and influenza vaccines. Co-administration of these vaccines would facilitate uptake and reduce the number of healthcare visits required. The ComFluCOV trial was designed to deliver the necessary evidence in time to inform the autumn (September-November) 2021 vaccination policy. This paper presents the statistical methodology applied to help successfully deliver the trial results in 6 months. ComFluCOV was a parallel-group multicentre randomised controlled trial managed by the Bristol Trials Centre. Two study statisticians, supported by a senior statistician, worked together on all statistical tasks. Tools were developed to aid the pre-screening process. Automated data monitoring reports of clinic data and electronic diaries were produced daily and reviewed by the trial team and feedback provided to sites. Analyses were performed independently in parallel, and derivations and results of all outcomes were compared. Set-up was achieved in less than a month, and 679 participants were recruited over 8 weeks. A total of 537 [at least] daily reports outlining recruitment, protocol adherence, and data quality, and 695 daily reports of participant electronic diaries identifying any missed diary entries and adverse events were produced over a period of 16 weeks. A preliminary primary outcome analysis of validated data was reported to the Department of Health and Social Care in May 2021. The database was locked 6 weeks after the final participant follow-up and final analyses completed 3 weeks later. A pre-print publication was submitted within 14 days of the results being made available. The results were reported 6 months after first discussions about the trial. The statistical methodologies implemented in ComFluCOV helped to deliver the study in the timescale set. Working in a new clinical area to tight timescales was challenging. Having two statisticians working together on the study provided a quality assurance process that enabled analyses to be completed efficiently and ensured data were interpreted correctly. Processes developed could be applied to other studies to maximise quality, reduce the risk of errors, and overall provide enhanced validation methods. ISRCTN14391248, registered on 30 March 2021.

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Concepts Keywords
3weeks COVID-19
Diary Influenza
Isrctn14391248 Randomised controlled trial
Vaccination Statistical methodology
Vaccination

Semantics

Type Source Name
disease MESH COVID-19
disease VO influenza vaccines
disease VO time
disease VO vaccination
disease IDO process
disease VO protocol
disease IDO quality
pathway REACTOME Reproduction
disease VO Optaflu
disease MESH influenza
disease MESH respiratory infections
disease VO vaccine
disease VO Flucelvax
disease VO Fluad
disease VO Flublok
drug DRUGBANK Ranitidine
disease VO dose
drug DRUGBANK Etoperidone
disease MESH causality
disease IDO intervention
disease VO frequency
drug DRUGBANK Coenzyme M
disease VO storage
disease IDO symptom
disease MESH pregnancy outcomes
disease IDO site
disease VO report
disease IDO blood
disease VO adverse event
drug DRUGBANK Spinosad
disease VO efficiency
drug DRUGBANK Tretamine
drug DRUGBANK Ilex paraguariensis leaf
drug DRUGBANK Methionine
drug DRUGBANK Pentaerythritol tetranitrate
disease VO prime boost regimen

Original Article

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