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. 2023 Mar 30;24(1):243.
doi: 10.1186/s13063-023-07251-x.

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK

Adam D N Williams  1 , Gwyneth Davies  2 , Amanda J Farrin  3 , Marion Mafham  4 , Michael Robling  1   5 , Matthew R Sydes  6   7 , Fiona V Lugg-Widger  8
Affiliations

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK

Adam D N Williams et al. Trials. .

Abstract

Background: Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data.

Methods: This three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups.

Results: In the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation).

Conclusion: This prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised.

Keywords: Consensus; Priority setting; Routinely collected data; Trials methodology.

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Conflict of interest statement

GD reports speaker honoraria from Vertex Pharmaceuticals and Chiesi Ltd., unrelated to the current manuscript. MM works for the Nuffield Department of Population Health which has a policy of not accepting personal payments from industry (https://www.ndph.ox.ac.uk/files/about/ndph-independence-of-research-policy-jun-20.pdf). A list of grants to the department is available in this document. MM is a co-applicant on research grants to the University of Oxford from Novartis and Novo Nordisk. AJF is a member of the MRC Better Methods, Better Research (BMBR) panel funding methodological research, unrelated to the project funding for this manuscript. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Frequency of questions appearing in the top 10. Question numbers relate to the order of questions shown in Additional file 2
See this image and copyright information in PMC

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