Interview Dorothea Kesztyüs
Since October 2023, the NWG (junior research group) CDS2USE has been coordinating a networking initiative at the University Hospital Carl Gustav Carus Dresden. The aim of this initiative is to increase the visibility of the NWG and to focus on the work of young researchers.
In this context, we would like to introduce you to exciting junior research groups, projects and personalities such as Ms Dorothea Kesztyüs from the NWG FAIRRMeDIC from the HiGHmed network.
Mrs Kesztyüs, your junior research group focuses on the training of young scientists in the development and evaluation of scientific methods in a MeDIC. Could you please explain in more detail what this means?
In order for the data collected in a MeDIC to be used for the best possible patient care, knowledge in the field of medical data science is required above all. According to the definition of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS), ‘Medical Data Science’ (MDS) is an interdisciplinary field whose methods provide the basis for the best possible knowledge from medical data. This includes data generation in the context of medical care, ensuring data quality and storage, as well as data analysis strategies, machine learning methods and modelling.
The promotion of our young scientists is therefore focussed on learning and applying the methods of MDS as part of the further development of our MeDIC. This applies with regard to the quality of the data, in particular the reliability of the integrated data, which is of crucial importance for the insights to be gained from it. The maximum protection of patients against de-anonymisation is another prominent priority, which is why it should be possible to quantify the re-identification risk of an extracted data set before it is released and, if necessary, take appropriate protective measures. Finally, data security will be increased by introducing strict change control processes that protect the stored data from unplanned changes and make changes traceable at all times. Procedures used in the strictly regulated framework of clinical and pharmaceutical studies will also be tested for their suitability for the MeDIC.
In view of the immeasurable value of the data collected in the MeDICs, the scientific training of experts in the handling of this data is a major investment in the future, with a high expected return on investment for our future healthcare system.
Could you start by explaining what is meant by real-world data and what significance it has in modern medicine?
There are various definitions for the term ‘real-world data’ (RWD), which primarily relate to how the data is collected, for what purpose and from which sources. RWD are usually non-interventional, i.e. they do not come from randomised controlled trials (RCTs), but are collected routinely. They are used for decision-making purposes or to analyse the effects of health measures and originate from routine clinical practice, for example from hospitals, doctors' practices, registers, payers, insurance companies, etc. In the MeDIC of the University Medical Centre Göttingen (UMG), this is therefore routinely collected data from a maximum care hospital. This RWD can be used in a variety of ways, not only for the development of systems for clinical decision support, but also for the generation of so-called ‘real world evidence’ (RWE), which is increasingly being used to complement findings from RCTs. Drug authorities such as the US Food and Drug Administration (FDA) have long been using RWD and RWE to monitor and evaluate the safety of authorised drugs after they have been placed on the market.
Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support regulatory decisions. RWD and RWE can thus accelerate the development of medical products and bring new innovations and advances to the patients who need them more quickly and efficiently. In addition, the development of evidence-based practice also requires the corresponding practice-based evidence that can be obtained by analysing RWD, e.g. from electronic medical records or registry data. In this way, findings from everyday practice provide important information from the real everyday care of millions of patients (big data analyses) for millions of patients and thus also serve as a possible corrective for results from the isolated world of RCTs, which lack precisely this external validity that RWE can provide.
Against this background, the UMG-MeDIC and the FAIRRMeDIC junior research group have set themselves the task of making RWD available to interested researchers with a high degree of quality and reliability. The reliability of RWD in particular is crucial, as pointed out by many relevant institutions and experts, who also call for a posteriori control of data quality in secondary data utilisation. Researchers and reviewers should be able to systematically assess the suitability of RWD by carrying out verification tests to evaluate reliability and thus avoid the phenomenon of ‘garbage in - garbage out’.
What particular challenges do you see in the area of data protection, and what role does international cooperation play in this context?
I would like to answer this question against the background of the objectives of our junior research group, as otherwise I would have to go too far in view of the rapid expansion of data sources, collections and possible uses, even if one wanted to limit it to the medical field.
To pick up on a very topical keyword that we are also increasingly encountering at MeDIC, what is the situation regarding data protection for data that is required for the development of processes with artificial intelligence (AI)? Here too, the increasing use and growing volume of RWD naturally goes hand in hand with major data protection requirements. In principle, AI and RWD have great potential to improve healthcare, but given the international availability of the underlying data, cross-border cooperation is essential to protect the anonymity and privacy of the people from whom this data originates. Above all, close cooperation between politics and research is required in order to translate scientific findings regarding the vulnerability of RWD and potential protective measures into regulatory processes as quickly as possible.
How do you assess the future development of data protection in MeDICs? What new challenges do you think we could face in the future?
The same applies to data protection in MeDICs as to the international protection of RWD. However, MeDICs, at least in Germany, should be proactive and anticipate the ethical and legal challenges posed by the use of data and take appropriate measures before the relevant authorities issue the necessary regulations.
More information on the NWG FAIRRMeDIC can be found here.