Cardiology societies urge rethink of randomised controlled trial design

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The current model for randomised clinical trials must be redesigned for the modern age, according to the European Society of Cardiology (ESC), American Heart Association (AHA), World Heart Federation (WHF) and American College of Cardiology (ACC).

The call comes in a joint statement which has been published simultaneously in the flagship journals of all four organisations: European Heart Journal, Circulation, Global Heart and Journal of the American College of Cardiology (JACC).

ESC President Professor Franz Weidinger (Landstrasse Clinic, Vienna, Austria), said: “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 provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernisation.”

The paper states that 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”.

The COVID-19 pandemic necessitated highly streamlined trials that were easy to administer in busy hospitals, the organisations claim, adding that only essential data were collected and much of the follow-up information was obtained from national electronic health records (EHRs) when possible. “In addition, digital advances have allowed app-based data collection, remote monitoring and virtual trial visits which can enhance efficiency while maintaining safety,” they add.

WHF president Fausto Pinto (Hospital de Santa Maria, Lisbon, Portugal), said: “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.”


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