The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies

Abstract

The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.

Keywords: Cardiovascular disease; Data and biomaterial collection; German Centre for Cardiovascular Research; Research platform; Standardisation.

Fig. 1

Translational pipeline of the DZHK: from breeding ground to guideline relevant studies

Fig. 2

DZHK research platform in the context of data acquisition and biological sample collection from patients recruited in DZHK studies (left, blue) and data as well as biological sample secondary use by scientists (right, red). The framework is defined by the Ethics and Data Protection Concepts as well as the DZHK Use and Access Policy. Study sites primarily use the IT systems for data documentation, while scientists interact with the Transfer Office. The Trusted Third Party enables record linkage and ensures proper pseudonymisation and adherence to informed consents

Fig. 3

Study sites. Red dots exemplify DZHK clinical study units which are characterised by a close link to the DZHK network and which are, in case of a sufficient recruitment and data collection performance, provided with DZHK clinical staff [3]. Blue dots are external recruitment centres that provide an important role in achieving the high recruitment numbers that are necessary to finish a clinical study within a reasonable time [21]. Red drops stand for DZHK sites providing parts of the clinical research platform

Fig. 4

Timeline of DZHK clinical studies with their different phases. The DZHK research platform supports all studies in the trial project phase including recruitment (red). The embargo period (green striped box) follows during which studies conduct their analyses. Typically two years after the end of the study data and biological samples are transferred to the DZHK Heart Bank and are available for secondary use (green). *As of December 2022 embargo period ended

Fig. 5

Seamless integration of TTP-system into the clinical data system incl. interaction of the involved entities