Leading Cardiology Organizations Call for Reinvention of Clinical Trials

The world’s largest and foremost cardiology organizations are joining together in a call to reinvent randomized clinical trials for the 21st century.

Released on December 16, the joint statement, which was created as a collaborative effort between the European Society of Cardiology (ESC), American Heart Association (AHA), World Heart Federation (WHF), and American College of Cardiology (ACC), was created to serve as a call to action to reinvent randomized clinical trials to be fit for purpose in the 21st century on a global scale.

“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 and the current model is unsustainable,” said Franz Weidinger, MD, ESC President, in a statement from the ESC. “Cardiology provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernization.”

A 4-page document, the statement itself was composed by leadership at the aforementioned organizations on behalf of the Clinical Trial Expert Group and ESC Patient Forum. Citing 22 references, the document opens by outlining the most pressing issues in the design and conduct of randomized clinical trials in cardiology own recent years. Following this portion, the writing group provides historic background and perspective on the impact of these issues on trials and, by extension, clinical practice.

Following the sections outlining the problem and background of the issue at hand, the writing groups dedicates a large portion of the document to outlining opportunities for global impact. These areas of opportunity included the streamlining of trial processes with the intent of reinventing simple trials to explore global impact, use of routine data to our advantage in trials and not as an inappropriate replacement, and a collaborative revision of the International Council for Harmonization Good Clinical Practice (ICH-GCP) Guidelines.

At the very start of the document, the writing group details 5 specific pieces of guidance for reinventing randomized clinical trials for the 21st century.

Guidance for 21st century randomized clinical trials:

• Based on key scientific and ethical principles and focused on issues that materially influence the well-being of trial participants and reliability of results.
• Clear, concise, consistent and proportionate, recognizing apparent risks associated with usual clinical practice and a lack of reliable evidence on intervention effects.
• Forward looking, fostering innovation in health intervention and trial methods, including the appropriate use of routine healthcare data, digital technology, and direct-to-patient designs.
• Promoting trials that are relevant to a broad and varied population as well as assuring diversity of participants and funded researchers.
• Flexible, widely applicable, utilizable, and durable, across disease areas, intervention types, development phases, trial designs, geographies, and time.

“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,” added Michelle Albert, MD, MPH, AHA President, in the aforementioned statement from the ESC. “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."

This statement, “Randomized trials fit for the 21st century. A joint opinion from the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation,” was published simultaneously in the European Heart Journal, Circulation, Global Heart, and Journal of the American College of Cardiology.