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

M Louis Handoko, Frances S de Man, Jasper J Brugts, Peter van der Meer, Hanneke F M Rhodius-Meester, Jeroen Schaap, H J Rik van de Kamp, Saskia Houterman, Dennis van Veghel, Alicia Uijl, Folkert W Asselbergs

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)


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.

Original languageEnglish
Pages (from-to)106-115
Number of pages10
JournalNetherlands heart journal
Issue number3
Early online date15 Jan 2024
Publication statusPublished - Mar 2024


  • Big data
  • Cardiovascular diseases
  • Heart failure
  • Pragmatic clinical trials
  • Randomised controlled trials

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