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Embedding routine health care data in clinical trials: with great power comes great responsibility

Handoko, ML; de Man, FS; Brugts, JJ; van der Meer, P; Rhodius-Meester, HFM; Schaap, J; van de Kamp, HJR; ... Asselbergs, FW; + view all (2024) Embedding routine health care data in clinical trials: with great power comes great responsibility. Netherlands Heart Journal 10.1007/s12471-023-01837-5. (In press). Green open access

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Abstract

Randomised clinical trials (RCTs) are vital for medical progress. Unfortunately, ‘traditional’ RCTs are expensive and inherently slow. Moreover, their generalisability has been questioned. There is considerable overlap in routine health care data (RHCD) and trial-specific data. Therefore, integration of RHCD in an RCT has great potential, as it would reduce the effort and costs required to collect data, thereby overcoming some of the major downsides of a traditional RCT. However, use of RHCD comes with other challenges, such as privacy issues, as well as technical and practical barriers. Here, we give a current overview of related initiatives on national cardiovascular registries (Netherlands Heart Registration, Heart4Data), showcasing the interrelationships between and the relevance of the different registries for the practicing physician. We then discuss the benefits and limitations of RHCD use in the setting of a pragmatic RCT from a cardiovascular perspective, illustrated by a case study in heart failure.

Type: Article
Title: Embedding routine health care data in clinical trials: with great power comes great responsibility
Open access status: An open access version is available from UCL Discovery
DOI: 10.1007/s12471-023-01837-5
Publisher version: https://doi.org/10.1007/s12471-023-01837-5
Language: English
Additional information: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Keywords: Randomised controlled trials, Pragmatic clinical trials, Big data, Cardiovascular diseases, Heart failure
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics > Clinical Epidemiology
URI: https://discovery.ucl.ac.uk/id/eprint/10186348
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