WP7

The objective of work package 7 is to organise the data quality and monitoring. Data from the HF registry should be fit for purpose for registry-based research. In addition, statistical analysis plans will be developed for registry-based research, including observational and Bayesian data analysis and adaptive inclusion for registry-based trials.

This work package focuses on:

• data analysis and fit-for-purpose of data for registry-based research.
• a thorough statistical analysis plan (SAP) for observational registry-based research.
• an infrastructure to allow for the conduct of Bayesian adaptive trials, which allow for modifications to one or more aspects of the design based on accumulating data. This infrastructure should serve as a blueprint for future registry based clinical trials in this population and cardiovascular disease domains other than heart failure (e.g. atrial fibrillation and coronary artery disease).
• a platform/statistical advisory board with expertise from different research institutes with expertise about registry-based research to support researchers within this specific field.
• an education module concerning data analysis of real-world data
• a DCVA health data hub to foster collaborations across all involved parties within the consortium.