According to the European Society of Cardiology (ESC), the current model for randomised clinical trials used in cardiology research must be redesigned.
The ESC has produced a joint statement with the American Heart Association (AHA), World Heart Federation (WHF) and American College of Cardiology (ACC) urging for a revaluation of the randomised clinical trial methods used in cardiology research.
The statement has been published in journals of all four organisations: European Heart Journal, Circulation, Global Heart and Journal of the American College of Cardiology.
Cardiology research can lead the way in clinical trial modernisation
“Randomised trials are the gold standard method for evaluating new therapies and improving patient care. However, the cost and complexity of trials are becoming prohibitive and the current model is unsustainable. Cardiology research provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernisation,” said ESC President Professor Franz Weidinger.
“Without sustained efforts to increase the application of streamlined approaches, and a more supportive regulatory environment for those who do choose to generate randomised evidence (instead of the adversarial approach that is often taken in regulatory audits), patients will suffer from important clinical questions not being addressed reliably, either because trials are too small or, due to excessive financial or bureaucratic obstacles, are never done at all,” stated the paper.
The COVID-19 pandemic meant that highly streamlined cardiology research trials that were easy to administer in busy hospitals were needed. During this period, only essential data was collected, and a large proportion of the follow-up information was obtained via national electronic health records (EHRs) when possible. Additionally, digital advances have enabled app-based data collection, remote monitoring and virtual trial visits which improve efficiency while maintaining safety.
“The pandemic reinforced the value of digital technology in healthcare and demonstrated the power of partnerships in global health. It also showed the importance of using digital tools to improve the organisation, development, and implementation of clinical trials, essential to drive innovation in care and meet unexpected challenges such as a pandemic. The future of clinical investigation needs to be carefully tailored to address the several challenges it faces, and digital technology will certainly play a major role,” said WHF President Professor Fausto Pinto.
EHRs can revolutionise research methods
The potential of EHRs for trial recruitment and follow up treatment is significant. Restricted access to records and reluctance from regulatory authorities to accept EHR-based outcome data means the resource is still relatively underused. However, a disproportionate amount of emphasis is placed on observational analyses of routine healthcare data to bypass the challenges of randomised trials.
“With this document, our societies wish to engage in the development of guidance that allows broader use of real-world data, housed in routine EHRs, to conduct the trials that are needed to improve patient care along with addressing unmet medical needs. Pragmatic clinical trials that allow flexibility while promoting innovation are required to address health care needs for different racial, ethnic and socioeconomic groups. This guidance is also an opportunity to have a close look at the real-world implementation of care practices designed to improve health equity,” AHA President, Dr Michelle A. Albert.
