The current model for randomized clinical trials is unsustainable and must be redesigned for the 21st century, according to a joint statement from the ACC, European Society of Cardiology (ESC), American Heart Association (AHA), and World Heart Federation (WHF).

The statement highlights the current challenges with the present clinical trial model, including a lack of diversity and under representation among population groups, a lack of consensus around “best regulatory practice, and the premature halting of potentially effective treatments based on financial grounds.”

“Randomized trials are the gold standard method for evaluating new therapies and improving patient care. However, the cost and complexity of trials are becoming prohibitive,” said ESC President Franz Weidin, MD, FACC. “Cardiology provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernization.”

ACC, AHA, ESC and WHF leaders authoring the statement suggest several ways to address the challenges by streamlining the clinical trial process and reinventing simple trials with global impact. For example, they note that the COVID-19 pandemic necessitated highly streamlined trials that were easy to administer in busy hospitals. 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.

“The pandemic reinforced the value of digital technology in health care and demonstrated the power of partnerships in global health. It also showed the importance of using digital tools to improve the organization, development, and implementation of clinical trials, essential to drive innovation in care and meet unexpected challenges such as a pandemic,” said WHF President Fausto Pinto, MD, PhD, FACC.

Other solutions include leveraging EHRs for trial recruitment and follow-up, as well as collaborative revision of the International Council for Harmonization Good Clinical Practice Guidelines, which are intended to ensure the safety and rights of trial participants and safeguard patients impacted by the results, but are often over-interpreted and thus impede the conduct of affordable clinical trials.

“The ACC, ESC, AHA and WHF fully support adoption of the revised guidelines put forth by the Good Clinical Trials Collaborative that keep the best parts of existing clinical trial guidelines, while also acknowledging new innovations and technologies available to clinical trial researchers both now and looking to the future,” said ACC President Edward T. A. Fry, MD, FACC. “In a rapidly changing and increasingly global world, there is no excuse for clinical trials not to keep pace with recent advances.”

“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,” said AHA President Michelle A. Albert, MD, FACC.

The joint statement was published simultaneously in the flagship journals of all four organizations: European Heart Journal, Circulation, Global Heart and Journal of the American College of Cardiology.

Read the joint society press release, here. Access CardioSmart’s Clinical Research Infographic, as well as other patient-facing education regarding the importance of clinical trial participation at CardioSmart.org/Research. Learn more about ACC’s Upping Your Game: Clinical Trial Research program designed to foster diversity and grow the pipeline of clinical trial researchers.

Clinical Topics: Cardiovascular Care Team, COVID-19 Hub

Keywords: Digital Technology, Mobile Applications, Follow-Up Studies, Data Visualization, COVID-19, ACC International

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