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Report – How to facilitate the use of healthcare systems data in cardiovascular clinical trials

Authors: BHF Data Science Centre;

Report – How to facilitate the use of healthcare systems data in cardiovascular clinical trials

Abstract

The use of healthcare systems data could facilitate cheaper and more efficient clinical trials while maintaining the highest standards. We report the BHF Data Science Centre’s findings which highlight barriers to the use of healthcare systems data in cardiovascular (CVD) clinical trials. These include: difficulties discovering what datasets are available and how to access these; navigating the complex bureaucracy, consent, and ethics, and obtaining information or guidance on this; and challenges associated with the costs of accessing data, understanding the costing model, and obtaining transparent and consistent cost estimates. We outline our plans to address the challenges and facilitate the use of healthcare systems data in CVD clinical trials, ultimately increasing the proportion of trials that use such data.

Keywords

clinical trials, data-enabled clinical trials, cardiovascular disease, health data

13 references, page 1 of 2

1. Martin, L., Hutchens, M., Hawkins, C. & Radnov, A. How much do clinical trials cost? Nat. Rev. Drug Discov. 16, 381-382 (2017).

2. Moore, T. J., Heyward, J., Anderson, G. & Alexander, G. C. Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a crosssectional study. BMJ Open 10, e038863 (2020). [OpenAIRE]

3. Lensen, S. et al. Access to routinely collected health data for clinical trials - review of successful data requests to UK registries. Trials 21, 398 (2020).

4. MacArthur, J., Morrice, L., Sudlow, C. & Sydes, M. BHF Data Science Centre: Data-Enabled Trials Survey Report (0.1). Zenodo doi:https://doi.org/10.5281/zenodo.5079178.

5. National Cardiac Surgery Clinical Trials Initiative. https://le.ac.uk/cardiovascularsciences/about/heart-surgery/national-cardiac-surgery-clinical-trials-initiative.

6. Challenge statements gathered during BHF DSC cardiac surgery workshop. https://www.hdruk.ac.uk/wpcontent/uploads/2022/03/BHF_DSC_Cardiac_surgery_workshop_Challenge_statements_gathere d.xlsx.

7. Sydes, M. R. et al. Realising the full potential of data-enabled trials in the UK: a call for action. BMJ Open 11, e043906 (2021).

8. The Gateway. https://www.healthdatagateway.org/.

1 (Long Term Outcomes and Quality of Life)

1 (Long Term Outcomes and Quality of Life)

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  • citations
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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  • 512
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    373
    downloads
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visibility
download
citations
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
views
OpenAIRE UsageCountsViews provided by UsageCounts
downloads
OpenAIRE UsageCountsDownloads provided by UsageCounts
0
Average
Average
Average
512
373
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